The Ethical Challenge and Surgical Innovation

 Updated 3/2017 -- all links (except to my own posts) removed as many no longer active and it was easier than checking each one.

The short articles referenced below make for thoughtful, interesting reading. I had a similar discussion once during an ethics CME course I took. Most there thought that any “change” in an operation was risky and maybe unethical as the surgeon was “not trained” for it. My view point as I tried to explain it, was that like dress-making or tailoring, surgery is based on good skills. If I know how to put in a zipper or do a collar or do button-holes well, then you can put all those together to do more than just make a dress. I should be able to put those skills together to make a suit coat. That simple example opened (didn’t necessarily change) up the minds of most there.

That example is way too simple and there do need to be ways to make sure that surgeons who left their residency PRIOR to learning a technique that came along ten years later (laproscopy is a great example) have properly learned the technique prior to being given hospital privileges. What is the learning curve? Who should oversee them while they do their first six or ten or twenty cases? What if they are the first in the community to learn the skill (went to the university and took a week long course)?

Here are some short bits to entice you. This is from Dr Clayman.

The challenge for the surgeon as a creative being is that unlike all other arts, the surgical medium is sensate. Every alteration in a tried-and-true technique
exposes both the surgeon and patient to censure and unknown complication, respectively…….

The question arises, at what point along the creative continuum does a minor variation on a theme become an innovation? When does the surgeon-scientist need to ask or request a panel of peers to review an idea or concept and judge it—seeking permission prior to performance? How well equipped is the average institutional review board (IRB) panel, all too often composed of a minority of surgeons, able to pass judgment? ………….

The surgeon today, through technology, seeks to accomplish a surgical cure while lessening surgical
morbidity, hence the advent of minimally invasive surgery. However, as the incision wanes, the technology waxes and thus the surgeon must now enter a realm unfamiliar, that of the medical industrial
complex. While the surgeon is thinking less pain, quicker convalescence, better cosmesis, the industrial
side of the partnership is evaluating potential profit/loss, marketability and expense of development. In this light, it is essential that the IRB stand between the innovator and the patient, just as the FDA now stands between industry and the patient….

In this regard the sage advice of Dr. Agich bears repeating: “We need a well-grounded set of criteria to differentiate at least three types of cases: routine or
normal variation; innovation that is beyond routine, not formal research, yet requires review; and innovation that involves research and so requires formal IRB review.”

However, as with most gradations, the extremes are obvious (one and three), it is the middle ground (two) that provides the greatest challenge and concern…….

Both articles are worth reading and discussing.
REFERENCES
Dialogue: The Ethical Challenge Posed by Surgical Innovation by Ralph V Clayman, MD with Response by George J Agich, PhD; Lahey Clinic Journal of Medical Ethics, Fall 2008, Vol 15, Issue 3, pp 6-7 (pdf file)
The Ethical Challenge Posed by Surgical Innovation by George J Agich, PhD; Lahey Clinic Journal of Medical Ethics, Spring 2008, Vol 15, Issue 2, pp 1-2 (pdf file)