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	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

Casler's thoughtful review¹ of the role of oversight agencies (eg, Food and Drug Administration and local institutional review boards [IRBs]) in the development and application of new devices and surgical procedures discusses the pros and the cons of such oversight while emphasizing the need for patient safety and ethical safeguards.

The article raised an important issue about the distinction between surgical innovation and research. This is a murky area that currently has no accepted definitions. Given the position of some ethicists on the subject²—calling for standardization, monitoring, and increased oversight—a dialogue on this issue is timely. It appears to me that innovative surgery, experimental surgery, and surgical research are 3 different things.

Surgery is a technical art based in science. For all the scientific advances in the field, surgeons are still fallible human beings committed to the safety and well-being of their patients. The surgeon is a skillful artisan, . . . [Full Text of this Article]

George A. Gates, MD
Department of Otolaryngology–Head and Neck Surgery
University of Washington
Seattle, WA 98195
(e-mail: ggates@u.washington.edu)

RELATED ARTICLE

Surgical Innovation and Research—Reply
John D. Casler
Arch Otolaryngol Head Neck Surg. 2003;129(12):1354.
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