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.”
