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Surgeons often face gray areas in which individuals might disagree over whether a particular treatment is merely aggressive or experimental, says Gerald Fried, MD, head of laparoscopic surgery at McGill University and head of gastrointestinal and laparoscopic surgery at Montreal General Hospital in Canada. The key sometimes is how much the procedure is different from whatever was done before, he says.
"If you’re going to make small innovations, small changes, then there’s really not a huge burden both ethically and legally," he says. Using a new type of instrument, or even a new type of access to the patient may be novel, for instance, but it poses little or no risk to the patient. There fore, the need to seek approval and inform the patient is lessened.
Fried made his comments, along with several other surgeons, at a recent surgery conference in San Antonio. Unusual and daring treatment sometimes is justified by the situation, Fried says. The mere fact that a procedure is unproven does not necessarily mean it should not be used, he says, but he cautions that unproven treatments present more than the usual burden of informing the patient. In addition to the standard informed consent, an experimental approach demands that you explain the nature of the innovation so the patient clearly understands the situation.
"We must give our patients a clear description of what we’re going to do to them, the risks and benefits, and the prior experience both worldwide and in our own experience," he says. "You must remember that patients are highly susceptible to our recommendations and our enthusiasm. You also must recognize that each of us goes into the situation with a built-in bias to do the procedure because we are surgeons and we want to advance science and build up our own experiences."
Surgeons should be urged to use a low threshold for seeking approval from the institutional review board (IRB), he says. Another word of warning comes from Steven Stain, MD, associate professor of surgery at the University of Southern California School of Medicine and director of the surgical residency program at Huntington Memorial Hospital in Pasadena, CA. Many surgeons think they know more about the requirements for clinical trials and institutional rules on surgical innovations than they actually do, he says.
"We define novel procedures as those that may be unproven, and they may pose additional risk to the patient," Stain says. Novel procedures can be distinguished from research, however. Research usually involves surgical procedures in which a certain task is performed or a certain approach used for the purpose of gathering data, rather than purely for the purpose of patient care, he says. Other factors, such as industry sponsorship, can push a procedure from the "novel" category to the "research" category.
A novel surgical approach is less likely to require IRB approval, Stain says. Research probably needs IRB approval.
Don’t go overboard in depending on IRB approval as a risk management tool, however. IRB approval may not be especially helpful in defending a malpractice case, says Kenneth Kern, MD, attending surgeon and associate clinical professor of surgery at Hartford (CT) Hospital and the University of Connecticut School of Medicine in Hartford. Kern has studied surgery malpractice for years and says juries are likely to see IRB approval as merely an administrative endorsement.
"As far as I can see, IRB approval would be a negative if you didn’t have it, but, if you did have it, I don’t think it would offer any significant benefit in your defense," he says.