Researchers and IRBs sometimes have questions about studies and treatment that fall in the gray area between research and personalized medical care. Is it innovative care that is intended to benefit a specific patient — or an innovation that has the potential of being generalizable?
Another question to ask is whether the intent is to practice nationally or broadly in a specific discipline, says Jeremy Corsmo, MPH, senior director of research compliance and regulatory affairs at Cincinnati Children’s Hospital, and assistant professor of pediatrics at the University of Cincinnati College of Medicine.
“For me, this is whether this is research and you need IRB oversight, or whether this is the practice of medicine,” Corsmo says.
Distinguishing between research and innovative and/or medical care is tough in the area of surgical technique, he notes.
“It’s not regulated by an outside entity, and it naturally requires some level of flexibility during the procedure,” he says. “When you start a surgery, you may not know exactly what will happen when you get going.”
Studies that involve devices regulated by the FDA need IRB approval, Corsmo says.
Other activities are less black and white. For instance, comparative effectiveness analyses might require an IRB review, depending on what is in the study. If the intention is to compare approved interventions to determine which one would be more effective, then it could be an expedited review, Corsmo says.
“It depends on how much control the investigator is planning to exert through the study, and which intervention they use,” he adds.
Intent also is an issue. This might require trust in what physicians say they intend to do with the surgery or activity, he adds.
“When they did this surgery and came up with a new approach, was it purely out of the need to take care of that patient, or are they going into a surgery or set of surgeries with the idea of ‘I have an idea and want to evaluate how it works?’” Corsmo says. “That intentionality drives whether or not they are doing research or patient care, and you have to have that trust in what the person is doing.”
The only way to divine a physician’s intent is to ask. “You have to have a conversation with them and ask what their intent is,” Corsmo says. “You could spend a lot of time trying to catch the bad actor, but I think you have to trust your skills as an administrator or compliance person and just have that conversation with the individual to understand what their intent is.”
One obvious red flag would be this type of answer: “I have this new technique, and I’m going to use it on the next five patients.”
“That doesn’t sound like someone who is making an independent decision to do what’s in the best interest of each individual patient,” Corsmo says. “It would lend itself more toward a scientific investigation, which would need, potentially, an IRB review.”
It would be challenging for a research organization to create steadfast rules to separate research from medical care or innovative care. But some research medical centers might have a surgical innovations committee, he notes.
An innovations committee might participate in academic or peer discussions about innovative techniques and could speak with surgeons, suggesting they talk to IRBs, as needed.
“We don’t have that at our institution, but we have a very open IRB office and frequently have conversations like that with people,” Corsmo says.
IRBs also might have a say in what is standard of care vs. an investigational activity.
“The IRB, as part of its review, will ask or have to evaluate what is the standard of care at our institution and in this discipline,” Corsmo says. “We haven’t had circumstances with contentious issues in trying to assess what is the standard of care.”
In addition to being involved in decisions about what is research, what is standard of care, and what is innovative care, IRBs also might be involved in educating inexperienced researchers and medical residents in these differences.
“As part of the orientation that our residents get, there is a presentation module they take about what is research,” Corsmo explains. “It addresses the circumstances and references of when someone might be crossing the line of clinical care into research. Most of our residents will be actively involved in a research project, so it’s not necessarily foreign to them — as it’s part of their training.”