IRB: Ethics & Human Research
Cutting into the Spongy Belly of Surgical Innovation
Surgeons are generally free to make changes in operative procedures—from minor to major—without any need for approval from the Food and Drug Administration. This raises a host of fascinating issues about how we are protecting—or should be protecting—patients who undergo such new treatments. The relatively scant literature on this topic has now been greatly supplemented by the publication ofEthical Guidelines for Innovative Surgery, a collection of essays edited by Angelique Reitsma and Jonathan Moreno.
Key words/concepts: FDA oversight, innovative surgery, requirements for IRB review