Research Ethics and Surgical Innovation On and Off the Battlefield

A recent story in the Wall Street Journal highlights the fact that, on battlefields today, urgency, acuity and need are still drivers for surgical innovation.

Here’s the story: On Battlefields, Survival Odds Rise

Every war brings medical innovations, as horrific injuries force surgeons to come up with new ways to save lives. During the Civil War, doctors learned better ways to amputate limbs, and in World War I they developed the typhoid vaccine. World War II brought the mass use of penicillin, Korea and Vietnam the development of medical evacuation by helicopter.

The lessons of Iraq and Afghanistan, medical experts say, are still emerging. One legacy is new ways to control bleeding before soldiers lapse into comas or their vital organs shut down. Thanks to new clotting agents, blood products and advanced medical procedures performed closer to the battlefield, wounded American soldiers are now surviving at a greater rate than in any previous war fought by the U.S.

The notion of surgical innovation as a driver of change and new approaches to old problems is not a new one. For many years, there has been a discernible tension between those who feel surgeons should not be conducting “renegade research” in their operating rooms and those who feel that surgical innovation should be considered to be outside of the reach of research ethics review and simply left up to surgeons. Having been in and around an operating room for a good portion of my clinical career, I know that decisions to do innovative or unusual things in a surgical procedure are often made at a time of great urgency — at a moment when one person literally holds the life of another in their hands. Out of these kinds of time-constrained, often life-saving critical decisions come ideas for new approaches and innovative methods by which surgeons can deal with problems that have traditionally been barriers to operative success. And operative success means saving lives. In the WSJ story noted here, the innovations that military surgeons are doing on the front lines are, in fact, saving lives right now and may, in the future, contribute to life-saving surgical advancements in other contexts outside of the military.

In many ways, the world of research ethics review and the world of surgical innovation have found ways to both co-exist and to respect each other. Surgical innovation is seen as a legitimate method of inquiry (today there is even a journal of Surgical Innovation) and one in which research ethics review plays a part, but at a point in the process that makes sense. Obviously, it’s impossible to enforce ethics review processes on surgeons every time they enter the operating room to do a riskier or more complex procedure. Surgical innovations are not planned — they happen in a much more organic way.
It’s only when the surgeon says, “Well I could do the new thing I just did here to the next bunch of patients I have with this problem and see if it works”, that research ethics review is required.

What struck me most about this story was the emphasis on the kinds of innovations occurring on the front lines without someone crying out for formal research ethics involvement and monitoring. The relationship between the processes of surgical innovation and research ethics is a great example of how common sense and mutual respect have made both processes more rigorous, more relevant and more, well, satisfying. Surgeons clearly place a high value on not feeling constrained at a time when doing something highly experimental is the only way to save a life. For ethics review board members in clinical settings, there is something really very satisfying about reviewing and approving a protocol to allow a trial of a proposed new approach to treating heart disease or complex cancerous tumours in kids without being seen as a barrier to innovation — but instead a facilitator of well-intentioned change, surgical advancement and maybe even a new way to save lives.

~ by Nancy Walton on April 9, 2010.

One Response to “Research Ethics and Surgical Innovation On and Off the Battlefield”

  1. I agree that surgical innovation is a real challenge. The biggest problem is when innovation is used as an excuse to avoid IRB-ethics board review. The surgeon uses the same novel method a few times, then decides to write it up, ex post facto. When should that line be crossed, when others should look at the research and make a determination that the risks and benefits are fair, that the surgeon is being honest in his generally unregulated consent process? How much oversight should there be? Not easy…
    Ross McKinney, Jr. MD – Duke

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