Drafting a Canadian health policy for rare diseases

U of T researchers say Canada needs to create new framework to broaden access

Drafting a Canadian health policy for rare diseases

In the last federal budget, the Canadian government committed one billion dollars over two years, starting in 2022, to cover the costs of health care related to rare diseases. Canada’s relative lack of a rare disease policy opens conversations on what should be included in an effective strategy to provide Canadians better access to drugs for these ‘orphan diseases.’

Dr. Joel Lexchin, an associate professor at U of T’s Department of Family and Community Medicine, and Nicholas Moroz, a recent Master of Public Health graduate at U of T, published a paper on the subject. It analyzed whether a rare disease policy similar to Australia’s could be effectively implemented in Canada to broaden the availability of treatment options for patients with rare diseases in the country.

The state of orphan diseases in Canada

Orphan diseases are rare diseases that affect approximately five people in 10,000. These diseases have been the subject of policy discourse in Canada for more than two decades, yet no policy has been set, according to the authors. 

Now, as legislators have a go-ahead from the government for investing in orphan drug treatments, they must also consider the best policy for regulating them.

Health Canada currently has two regulatory pathways in place that facilitate the speedy delivery of orphan drugs to the market. These provide patients access to orphan drugs in the interim of passing a formal policy, according to the authors. 

The first is the priority review, which takes 180 days, instead of the standard 300-day review. The second is a 200-day conditional approval of drugs based on limited clinical data. 

Would an orphan drug policy be beneficial?

To determine if a drug policy such as Australia’s would be beneficial to improving access to drugs, Lexchin and Moroz looked at the frequency and speed drugs assigned an ‘orphan’ status by the US Food and Drug Administration (FDA) were approved by Australia and Canada. 

The paper does not suggest that an orphan drug policy like Australia’s would help improve access to medicine in terms of speed or variety. 

The conclusions showed that both Health Canada and the Australian Therapeutic Goods Administration (TGA) approved 74 of the 119 drugs designated for orphan diseases by the FDA. Health Canada shows more propensity for approving drugs, as it approved an additional 11 drugs, while the TGA only approved four other drugs. 

There was no significant difference between the approval rate by Canada and Australia. 

Why do we even need an orphan drug policy?

Australia’s orphan drug policy is focused on getting drugs to the market rapidly. However, the authors noted that Canadian lawmakers could help patients by considering other objectives, including incentives for drug development and economic accessibility. 

While Australia implemented fee waivers for applications for orphan drug status and annual registration, its policy does not guarantee market exclusivity, grants, or tax credits targeted at orphan drug research. Lexchin and Moroz think that such a framework would help provide developmental incentives for new drugs, which is one of the objectives that they argue Canada should include in orphan drug framework. 

When it comes to economic accessibility of orphan drugs, the study recommends that the government include public subsidies and reduce the price charged by companies.  

There is no evidence that having an orphan drug framework similar to Australia’s would make Canada a more attractive market for orphan drugs, wrote the authors. They concluded that in order for Canada to provide quicker access to orphan drugs, it is essential for the policy framework to be much different than the one in place in Australia.

How augmented reality could impact the future of surgical training

Study demonstrates how smart glasses could be used to train surgeons

How augmented reality could impact the future of surgical training

Augmented reality could hold promise for improving surgical training, using the Osterhout Design Group (ODG) R-7 Smartglasses, according to a recent study conducted with the University of British Columbia (UBC).

A research team, which included Dr. Neil Chadha, a former fellow at The Hospital for Sick Children in Toronto, recruited staff surgeons and resident trainees to participate in the study at Vancouver General Hospital. Resident trainees used the ODG R-7 Smartglasses to perform a synthetic surgery for educational purposes in the temporal bone cadaver drilling laboratory .

Applying the use of Osterhout Design Group R-7 Smartglasses

One main aspect of the study involved the use of a device to create an augmented reality. For the research team, the decision to use the ODG R-7 Smartglasses was simple.

“The [ODG] already had partners doing research with the R-7 Smartglasses,” said Dr. Michael Yong, a resident physician at UBC’s Faculty of Medicine, and a co-author of the study, in an interview with The Varsity.

In terms of set-up, the research team further believed that the smart glasses would be suitable to the operating room due to their battery life and wear-ability. However, Yong noted that while the maximum two-hour battery life is not currently a concern, it could pose a challenge in the future during clinical situations.

The study’s design and results

The study was completed at Vancouver General Hospital with two supervisors and five resident trainees using the temporal bone cadaver drilling laboratory.

“The temporal bone-drilling lab is… something that every residency program in [otolaryngology, which concerns the ear, nose, and throat] has access to, and so it was an easy place for us to start,” said Yong. 

After the trials, the researchers collected comments and a completed survey from the supervisors and residents participating in the study. Many comments recognized the promise of augmented reality in advancing surgical training. However, they also noted areas of improvement with the techniques.

The strongest advantage of the smart glasses was their potential to communicate remotely and exchange editable images with other practitioners. Other reviews of smart-glasses technology have noted applications, including monitoring patient vitals remotely and review patient charts on the go.

Some of the suggested improvements of the teaching experience included better lighting with the glasses, reduced time for images to be processed, and the reduction of connectivity issues. One of the more notable suggestions was to avoid the temporal cadaver bone lab for such, due to drawbacks caused by drilling.

“When you’re drilling the skull, bone dust comes up into the air,” said Yong. “Usually we wear masks and protective goggles, but the R-7 glasses are not designed to be an industrial-grade protective goggles, and so, there’s openings on the sides of it and little spaces here and there, that allow for bone dust to come in.”

Further research is needed to make the use of this technology widespread. However, Yong remarked, “It’s just a matter of getting more institutions to do these kinds of feasibility studies, to do these kinds of tests and get some feedback as to how best we can adapt this rapidly-growing industry technology to surgery… in a useful and efficient matter.”

The promise of terpenoids for human health

U of T researchers examine plant compounds associated with cannabis, the smell of pine, Vitamin A

The promise of terpenoids for human health

The word ‘terpenoid’ is not only limited to rhyming with words such as meteoroid, avoid, and steroid — it also symbolizes organic compounds produced by plants that offer significant medicinal and pharmacological benefits to humans.

In a review paper, U of T scientists explored the vast role that these chemicals play in our everyday lives.

Co-authors Dr. Michael Phillips, an assistant professor at UTM’s Department of Biology; and Matthew Bergman, a graduate student at the same department, discussed the findings of this review with The Varsity.

Relevance of terpenoids

The presence of terpenoids can be found all around us. Vitamin A is an example, along with the chemical that is key to the unique smell of pine.

The review explained that terpenoids can “attract pollinators, repel herbivores, or attract herbivore predators.” This has broad impacts on fields such as agriculture. 

Terpenoids also feature heavily in cannabis. Specialized terpenoids include well-known compounds such as cannabidiol — also known as CBD — and tetrahydrocannabinol — THC. The compounds have been used for their “psychoactive, anxiolytic and anesthetic effects for thousands of years,” according to the co-authors. 

The ability to make these terpenoids evolved as a result of “selective pressures imposed by animals” on plants. A great sense of irony lies in the fact that these chemical compounds, which often serve as plant defence compounds against herbivorous insects, possess “fortuitous uses in medicine.”

The reason that these compounds are biologically active in humans is in part due to the fact that “our proteins are made up of exactly the same amino acids as the plant proteins,” noted Phillips.

Applications of the review

Phillips hopes to use his review “partly as a teaching tool but also [to] summarize the literature that is important for [his] field.”

Bergman also spoke about the implications that his research would have on non-specialists in biology. “There’s a lot of interest right now in medicinal plants and there’s a lot of confusion surrounding what are the active constituents,” he said.

By conducting the review, Bergman hopes to eliminate some of this confusion. This is important because “there’s a connection between [our research] and what [consumers] find in the grocery store,” added Phillips.

The future of terpenoid research

In many cases, terpenoid-based medications could hold promise in health care, “by virtue of the fact of how much common ancestry we share with herbivores that terpenoids evolved to affect,” noted Phillips.

While many terpenoids represent potentially beneficial compounds for humans, the “testing process is painstaking and resource intensive,” according to the review. This process is further obstructed by the fact that “many [terpenoids] are produced in small amounts,” and “only in response to elicitation.”

Additionally, while the amount of plant terpenoids that can be screened for therapeutic applications is still unknown, it likely surpasses over 100,000 variants, according to the co-authors. With a review of terpenoids completed, researchers now have a tool to develop plans for further research in the field of plant biochemistry.

How psychedelics could reduce existential distress for end-of-life patients

In conversation with Dr. Daniel Rosenbaum on the clinical promise of psychedelics in Canada

How psychedelics could reduce existential distress for end-of-life patients

Psychedelics — substances that cause dramatic changes in thought and perception — could play a unique role in alleviating existential distress in patients with life-threatening illnesses like cancer, according to a recent review.

A University of Toronto-affiliated paper has explored the potential of psychedelic medication to improve patients’ quality of life and alleviate suffering in end-of-life care.

Facing existential distress in end-of-life care

“Existential distress relates to the kinds of concerns people often have as they face end-of-life, or cancer recurrence,” said Dr. Daniel Rosenbaum, one of the article’s co-authors, in an interview with The Varsity.

The feelings of hopelessness, demoralization, and burden associated with existential distress can cause depression, anxiety, and significantly reduced quality of life in patients facing life-threatening illnesses.

Some psychotherapies have been developed to treat existential distress and help end-of-life patients restore their sense of dignity and meaning in life; however, no medication or pill currently exists for alleviating this form of suffering — until recently as research has shown promising potential in psychedelic therapies.

Classic psychedelics include various compounds that bind to and activate 5-HT2A receptors in the brain, such as psilocybin — which is found in certain mushrooms — and lysergic acid diethylamide, also known as LSD. They can induce mystical, transcendent experiences and deep feelings of positivity, which makes them ideal to treat existential distress, according to Rosenbaum.

How psychedelics could address this problem

Studies from as early as the 1950s have suggested potential applications of psychedelics in psychotherapy. However, research has been bogged down by challenges in designing methodologies that could test the efficacy of psychedelic medicines.

There were also ethical and safety issues — some studies were completed without informed consent, and caused lasting harm to participants. By the mid-’70s, these issues, combined with controversy around the spread of recreational psychedelic use, caused most of the research in this area to be discontinued.

A ‘psychedelic renaissance’ is breaking this decades-long gap in research, accompanied by contemporary methodologies that strive to overcome the shortfalls of their predecessors. For example, today’s studies recognize the importance of components such as psychotherapy sessions before and after the drug treatment, as well as the creation of a safe and comfortable environment for the treatment sessions.

These factors can be crucial to how patients respond to the treatment and as such, must be carefully managed.

Modern studies on the promise of psychedelics

Notably, two studies from Johns Hopkins University and New York University found that psilocybin therapy reduced anxiety and depression levels in patients with life-threatening cancers and various psychiatric disorders. Patients also reported other beneficial effects, such as a reconnection to life, increased confidence, and acknowledgement of cancer’s place in life.

The treatment caused some temporary increases in heart rate and blood pressure, but these were generally well-tolerated and did not appear to cause any severely adverse symptoms. Careful participant screening in most contemporary research also helps to ensure that participants do not have any family history or personal predisposition for psychosis, and are able to undergo the treatment safely.

Moreover, the benefits of psychedelic therapy were shown to have an immediate and lasting impact. Beneficial effects were sustained for six months or longer after a single treatment. The drug’s rapid onset may also be advantageous compared to conventional antidepressant medications, which may take several weeks to have an effect.

“If someone is suffering from profound depression or anxiety, we may not have sufficient time for the alleviation of certain kinds of suffering with conventional medication treatments,” Rosenbaum said.

Next steps of psychedelic research

Further research in psychedelic-assisted therapy is underway at various institutions in Canada and around the world. A trial at the Princess Margaret Cancer Centre in Toronto is currently studying the treatment of depression in palliative care patients using intranasal ketamine.

MDMA-assisted psychotherapy for the treatment of post-traumatic stress disorder is another area of interest, with research ongoing at Ryerson University and a multi-site study from the Multidisciplinary Association for Psychedelic Studies taking place in cities across the United States, Israel, and Canada, including studies in Vancouver and Montreal.

“It’s an exciting time for the field in Canada,” Rosenbaum said. “I think, in the coming years, we will start to see a number of new trials.”

Why you want your surgeon to practice mindfulness

U of T lab investigates new ways to train surgeons for the operating table

Why you want your surgeon to practice mindfulness

The fact that surgeons work in high-stakes environments is not surprising — often, lives depend on how well they perform in the operating room. But traditionally, new surgeons going through basic training wouldn’t have heard much about the emotional labour that goes into the job.

Historically, surgeons were expected to stay stoic, and have not had much of a platform to discuss dealing with the emotional challenges they may face. As The New York Times reported, medical schools and residency programs have avoided discussion of emotional responses among medical professionals.

But that view has been changing. “I think, more and more, we’re really looking at the surgeon as this holistic person, and what really needs to go into that to be that expert-level performer,” said Sydney McQueen, an MD and PhD candidate at U of T studying surgical performance, in an interview with The Varsity.

“Rather than just putting people through five years of surgical training and hoping that they come out at the end with all the skills they need, [we’re] really starting to identify what are all those skills… things we haven’t traditionally always thought about as explicitly.”

Labs like McQueen’s have been helping to introduce discussions about mental health and well-being into surgical training. She recently co-authored a study that identified which skills might help surgeons control their emotions in high-stress situations.

How mental skills from other fields could apply to surgery

Another co-author of this study was Dr. Siobhan Deshauer. Deshauser, who has personal experience as a professional musician, decided to take a cue from the fields of music, athletics, and military service, all of which have already begun to incorporate emotional intelligence into their training.

The lab interviewed 17 surgeons who had significant previous experience in one of these fields, asking them about mental health skills they had learned in their previous careers that might have transferred into surgery. Most of the responses ended up falling into a few different categories.

First, many respondents had routines for moments of acute stress, such as breathing exercises or mental scripts, which they would use to calm down and re-assess the situation. Some had developed habits which they practice at the beginning of a surgery to prepare themselves for stressful situations.

The co-authors noted that when the participants were feeling overwhelmed, they often paused, regrouped, broke their goals into manageable steps, and strategized to find the best path forward. The participants often explicitly learned these techniques from training in their previous fields.

Many also used techniques in their downtime to improve their mental and physical well-being, which generally helped them feel more calm and in control. Some discussed reflecting on surgeries and re-evaluating their responses to better prepare themselves for similar situations.

Potential impact of the conclusions on clinical practice

Surgery training still has a long way to go. However, studies like this one, which identify mental wellness skills that could help surgeons perform, are invaluable to its progress. Identifying these skills is only half the battle, and training surgeons to adopt them presents its own unique set of challenges.

Positive mental responses take years of practice to become automatic, and the more consciously surgeons have to think about maintaining a level of calm, the less attention they can dedicate to their work.

Any question about emotional skills also has to account for the variation between individuals, and not all students will benefit from learning the same techniques, as McQueen noted. But, in light of the surgical community’s attempts to solve such problems, seasoned surgeons are beginning to open up invaluable discussions about how they experience the operating room.

“There’s definitely been surgeons I’ve talked to that really try to make an effort with their trainees to have those conversations outside of the [operating room], and let them know… ‘This is what I was feeling in that moment, and I took a pause, I put my finger on the bleeder, and I took some deep breaths until I was personally ready to continue,’” said McQueen.

Knowing that they aren’t the only ones experiencing emotional challenges can be invaluable for current trainees’ self-confidence — and can help the newest generation of surgeons get a head start on building skills to overcome them.

UTSG: Invisible Challenges in Medicine

Being a medical trainee is a great privilege but it also holds a certain weight of responsibility – late nights spent studying, never-ending exams, countless extracurricular commitments, and the persistent struggle to establish some sort of work-life balance. In addition to all of this, mistreatment of medical trainees is another phenomenon that has been shown to be prevalent (17-95%).

Has it ever crossed your mind that as a medical trainee, you might be subject to discrimination and mistreatment by residents, staff physicians, patients, or even peers simply because of a part of your identity you cannot control? This can be related to your race, ethnicity, gender, physical appearance, sexual orientation, religious views , a visible/invisible disability, etc. It is believed that such mistreatment can have a negative impact on medical trainees, which is why it is problematic and worrisome that we often don’t know how to respond or deal with such mistreatment.

The purpose of this conference is to not only expand the dialogue around mistreatment, discrmination, and allyship, but to empower medical trainees with strategies on how to respond to such mistreatment – ideally before it occurs. The conference will feature two keynote speakers ( Dr. Nanky Rai and Ms Chika Stacy Oriuwa), three workshops designed to be as interactive and engaging as possible, and a panel of medical trainees, residents, and staff physicians who will be speaking on their lived experiences and answering your burning questions!

As medical trainees, so much is expected of us. In order to perform to the best of our ability, we deserve to be able to learn and work in an environment that is supportive of our differences as individuals, and in the case that it is not, we should be able to thrive in such environments.



9:30 am – 10:00 am: Arrival and Registration

10:00 am – 10:30 am: Keynote Speech: Dr. Nanky Rai

10:30 am – 12: 00 pm: Morning Workshop

12:00 pm – 1:00 pm: Lunch

1:00 pm – 1:30 pm: Keynote Speech: Ms. Chika Stacy Oriuwa

1:30 pm – 3:00 pm: Afternoon Workshop

3:00 pm – 4:00 pm: Panel


Workshop Descriptions;

Morning Workshops – 10:30 AM:

Microaggression & Verbal Harassment: How to Respond

This workshop will be in the format of “Theatre of the Oppressed” . This is a technique which uses theatre to promote social change by inviting members of the audience to become actively engaged in, and interact with performers who are acting out scenarios that highlight microaggression and verbal harassment in the medical environment. Participants will be invited to interject and change the course of the scenario. Thus, participants will not only be able to witness these issues, but will actively engage with them, and in doing so will be able to better understand how they themselves might respond if found in such a situation.

Allyship: How to Practice It

The concept of allyship is becoming commonplace within medicine but it is sometimes difficult to know exactly how to practice allyship as medical trainees in an environment in which we are newly becoming accustomed to. This workshop will begin with a discussion on privilege, followed by tangible steps on how to practice allyship. Participants will get a chance to use these practical steps to play the role of an ally in scenarios that feature a medical trainee being mistreated or discriminated against based on race, gender, physical appearance, sexual orientation, religious views, a visible/invisible disability, etc.


Afternoon Workshop – 1: 30 PM:

Intersectionality: Walk a Day in My Shoes

This workshop will be centered on an exercise where participants will go through their shift in the hospital as an individual who is seen as a visible/invisible minority. Participants will be encouraged to explore the challenges that may be associated with this ‘new identity’ and contrast it with how they may have walked through that space had they not identified as this individual or how this may be different from what they may be used to based on their own lived experiences. We understand that it would be impossible for us to fully understand the lived experiences of different groups of people, thus, we have made necessary efforts to collaborate with and seek assistance from various stakeholders to ensure that this workshop is as informed as respectful as possible.

A new tumour analysis technique could improve predictions for pancreatic cancer outcomes

Method could assist in developing treatment plans, reduce health care costs, says U of T-affiliated paper

A new tumour analysis technique could improve predictions for pancreatic cancer outcomes

A new tumour analysis technique has been created to tackle the most common type of pancreatic cancer, in a new U of T-affiliated study. This method could improve physicians’ ability to better predict how a patient will be affected by the cancer, as well as reduce the health care costs of this type of analysis.

The researchers investigated pancreatic ductal adenocarcinoma (PDAC), which is the fourth leading cause of cancer-related deaths in the world. It is predicted by scientists that PDAC could become the second leading cause of death by cancer by 2030.

The current system for analyzing tumours is flawed

Physicians currently use a three-tiered grading system to analyze tumours from PDAC. The system relies on the classification of tumours into three groups: well, moderate, and poorly differentiated.

The best tumours for pathological analysis are well differentiated, while the worst are poorly differentiated, according to Dr. Sangeetha Kalimuthu, an Assistant Professor at U of T’s Department of Laboratory Medicine & Pathobiology, in an interview with The Varsity.

Tumours in the middle of the scale are considered moderately differentiated. “Think of a well-formed ice cream,” she continued. “When it starts to melt, it gets all ugly and not really pretty to look at, so that’s in essence how a tumour behaves.

But a major problem with this current grading system is that most tumours from PDAC are identified as moderately differentiated. Tumours with this classification are of limited clinical utility, explained Kalimuthu, as they provide little useful prognostic information about the patient.

Recently, largescale studies have identified prognostically significant molecular subtypes in PDAC. Different subtypes of PDAC are associated with differing clinical outcomes.

However, direct identification of a patient’s molecular subtype of PDAC through molecular analysis is expensive and not readily available worldwide. 

New study offers cost-effective solution for overcoming limitation

The U of T-affiliated study, co-authored by Kalimuthu, identified specific structural — or morphological — patterns in PDAC tumours and presented a novel tumour classification system based on these patterns.

The new classification system presented in the paper correlates morphological patterns with the known subtypes of PDAC. This enabled physicians to identify the molecular subtype of PDAC without using costly molecular analysis.

Kalimuthu added that looking at tissue stains “is the standard bread and butter of pathology.”

“Taking a tiny piece of tissue that you get from a much larger tumour and sequencing it doesn’t give you a representation of the tumour,” she said.

“We look at these stains so we can actually get an idea of the tumour — nothing [such as other techniques like sequencing] gives you a better picture of [it].”

Future potential to integrate technique with artificial intelligence

An established procedure that provides precedent for this newly developed classification system for PDAC tumours is an existing grading system for prostate cancer tumours.

Researchers devised the system, called Gleason grading, in 1966. It similarly gave prognostic information for colon cancer patients.

Kalimuthu and her co-authors hope that their new tumour grading system can fulfill a similar role for PDAC.

In the future, Kalimuthu and her co-authors hope to validate the PDAC-based grading system with a larger cohort of pathologists, before incorporating the grading system into a clinical setting.

If they can achieve this, the improved system of prognosis could help guide physicians in developing treatment plans for patients with PDAC.

Since the new classification system is based on patterns, Kalimuthu believes it could one day be integrated with artificial intelligence.

“This classification system could be directly applicable with deep learning algorithms — so that’s the long-term goal.”

How physicians in Canada invent new surgeries

A conversation with Dr. Sunit Das on ethical oversight in surgery innovation

How physicians in Canada invent new surgeries

Taking risks and testing new ideas are the cornerstones of advancing science and technology. But when it comes to developing new surgical techniques, experimentation can be a matter of life or death for patients who volunteer.

To understand how and why surgeons innovate, The Varsity interviewed Dr. Sunit Das, an Assistant Professor at U of T’s Department of Surgery and neurosurgeon at St. Michael’s Hospital. 

Why innovate?

Although the practice of surgery has come a long way, there is considerable potential to improve surgeries in order to make them safer, quicker, more efficient, and less expensive.

“Engineers talk about the fact that it’s the existence of problems that drive their work,” explained Das. “And, in a way, surgical innovation could say much the same.”

Of course, innovation inevitably carries the risk of failure. Das explained that part of the ethical dilemma of surgical innovation stems from weighing the benefits of testing an unfamiliar technique against a proven and well-known procedure. 

The difficulty of this decision depends on the effectiveness of existing procedures. When surgeons test a new technique against one that is rarely effective, ethically it might not be a costly risk to take. For example, according to Das, physicians can often test new chemotherapeutic agents with patients who have recurrent cancers, since there are usually no effective alternative therapies for their conditions.

New surgeries for these conditions are often worth the risks. It is much harder to try to innovate when a technique that is relatively safe and effective already exists.

For any innovative procedure, ethical practice requires doctors to fulfill certain responsibilities when offering experimental treatments to patients. Currently, there is a four-step process in place for approving new surgical techniques in Canada. 

The stages of surgical innovation

Surgical innovation begins with preclinical work and the development of a technique. Stage 1 follows, at which surgeons use the experimental technique for the first time on a human patient. In this early stage, the goal is to determine the safety and efficacy of the procedure in a small, select group of patients.

In Stage 2, surgeons apply the surgical procedure to a broader selection of patients to determine the reproducibility of Stage 1’s results. They also determine how to best apply the intervention, as well as develop the technique’s efficiency.

Throughout the development of any new surgery, patients and their caregivers must give special consent to receive it. This suspends or modifies the duty of surgeons to minimize harm. By the conclusion of Stage 3, the new surgery becomes a standard procedure, removing the need for physicians to require special consent from patients.

How do experimental surgeries receive ethical oversight?

Monitoring the progress of surgical innovation is critical — a lack of oversight could lead to mistakes that present patients with unnecessary risks.

For many hospitals, Research Ethics Boards (REBs) ensure experimental techniques meet ethical requirements. When surgeons intend to make an experimental procedure available for patients, they must submit a clearly defined protocol to an REB for approval.

However, there are drawbacks to placing an REB in charge of surgery. To start, REBs often do not have surgeons on them. Service on an REB is a time-consuming responsibility and “time is one of the things that surgeons tend to lack,” said Das.

An REB’s oversight can also substantially slow the development of a surgical technique, said Das, in ways he believes are unnecessary.

To develop a surgical technique, explained Das, researchers undergo a process that is iterative. That is, surgeons often apply an experimental technique, learn how they could improve it during the process of the surgery, and change the protocol to reflect the improvement.

“The nature of an REB is antagonistic to [iteration],” said Das. Under an REB’s oversight, each time the surgeons decide to alter their protocol, they need to apply for an amendment, causing their application to require review by the REB.

While Das noted that the additional review does ensure that the REB is on the same page as the surgeons, he believes that an alternative approval process could increase the efficiency of surgical innovation.

The Surgeon-in-Chief as an alternative source of oversight

Das believes in placing the burden of responsibility on the Surgeon-in-Chief of a hospital to ensure that experimental surgeries meet ethical requirements.

The expertise of the Surgeon-in-Chief addresses the first perceived shortfall of REBs — that such boards lack physicians directly experienced in surgery. He noted that “there are nuances to the idea of surgical innovation [that he believes] are more available to a Surgeon-in-Chief than they necessarily might be to an REB.”  This could allow the Surgeon-in-Chief to have a better grasp of how an experimental procedure works.

Das also addressed the issue of REBs reducing efficiency. He said that a Surgeon-in-Chief with the onus of responsibility would allow “a type of communication and a type of nimbleness to change that simply is not inherent to the way that something works with an REB” and would therefore support iterative development.

“I think Toronto has been a leader in the world in terms of thinking about this problem [of obstacles to iteration],” said Das. In fact, he noted that the model of placing the Surgeon-in-Chief of a hospital in charge of oversight, instead of an REB, evolved at Toronto General Hospital.

Since then, institutions, such as St. Michael’s Hospital and Toronto Western Hospital, have adopted this model of ethical approval. As an advocate of this approach, Das has co-authored a paper about this in The American Journal of Bioethics. 

He acknowledged, however, that the model does have shortfalls. “One of the inherent dangers to placing the oversight element to innovation with a Surgeon-in-Chief is that there might be [conflicts of interest] that could get in the way of proper oversight,” he said.

A conflict of interest, said Das, could result from the promise of prestige of a successful innovation overshadowing the Surgeon-in-Chief’s responsibilities to the hospital, surgeons, and patients to ensure proper oversight when approving experimental procedures.

“For me, being involved in surgical innovation has had beneficial effects on my career and on my standing in the international community of neurosurgery. I gain prestige by work that I do as an innovator… and the hospital gains prestige from the work that I do,” said Das.

“There’s the danger that those risks, those responsibilities could be clouded by the possibility of benefit in terms of prestige to a surgeon and to a hospital by innovation.”

Always innovating

Surgeons think about research ethics to address the conflict between the goals of securing patient safety and improving patient outcomes by developing new procedures. They cannot advance what they offer patients without stepping outside a place that is comfortable and known. Taking risks is fundamental to making progress.

“Surgical innovation in a way is deciding to do something differently, despite knowing that we have a way of doing things safely and well,” said Das. “It’s simply that we think we can finally do something that, in a way, will be safer and be better.”