Both articles are worth reading and discussing.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…….
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)