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.
Gates GA. Surgical Innovation and Research. Arch Otolaryngol Head Neck Surg. 2003;129(12):1352–1353. doi:10.1001/archotol.129.12.1352-a
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