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Ann Thorac Surg 2006;82:1957-1965
© 2006 The Society of Thoracic Surgeons

Ethics in Cardiothoracic Surgery

Surgical Innovation: Too Risky to Remain Unregulated?

Haavi Morreim, PhDa, Michael J. Mack, MDb, Robert M. Sade, MDc,*

a University of Tennessee, Memphis, Tennessee
b Medical City Dallas Hospital, Cardiopulmonary Research Science and Technology Institute (CRSTI), Dallas, Texas
c Department of Surgery and the Institute of Human Values in Health Care, Medical University of South Carolina, Charleston, South Carolina

* Address correspondence to Dr Sade, Department of Surgery, 96 Jonathan Lucas St, Suite 409; PO Box 250612, Charleston, SC 29425 (Email: sader@musc.edu).

Presented at the Fifty-second Annual Meeting of the Southern Thoracic Surgical Association, Orlando, FL, Nov 10–12, 2005.

The first 300 words of the full text of this article appear below.


   Introduction
 
Robert M. Sade, MD
A recent investigation of cardiothoracic surgical studies involving human subjects (Annals of Thoracic Surgery and the Journal of Thoracic and Cardiovascular Surgery) showed that only 10% of such studies are randomized clinical trials, the gold standard for human research. This should not be surprising, because surgical studies are qualitatively different from medical investigations, for example, drug trials, in a number of ways. Surgical trial protocols that use placebo controls or controls with no treatment are often not ethical or not desirable, or both. Target populations for many surgical procedures are often quite small, so series large enough for accurate statistical evaluation may be difficult to develop. Double-blind studies are usually not possible because the surgeon-investigator must always know what he is doing. Most importantly, surgical procedures are characterized by a learning curve that leads to progressively improving skill in performing the procedure, and small incremental changes in the procedure itself lead to progressive improvement in results.

Most progress in surgery comes from innovation that does not fit into the category of surgical research. A commonly accepted definition of research is that contained in federal regulations regarding human subject research: "Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalized knowledge." Innovative surgery is often not systematic but is designed to benefit individual patients; there is often no intent to publish the surgical series at a later time, or such intent is secondary. Thus, most surgical innovation is outside the scope of "research" and not subject to oversight by institutional review boards (IRB).

A surgeon’s decision-making is generally motivated by pursuit of the patient’s best interests, yet other motivators lurk in the shadows; for example, pursuit of the surgeon’s interests, such as increasing personal income. Most surgeons recognize the importance of . . . [Full Text of this Article]




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