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Although the development of new drugs and medical devices is subject to regulation by the U.S. federal government, experimental surgery appears to remain virtually rule-free. There are regulations and guidelines for the participation of human subjects in medical and behavioral research, and there are federal laws pertaining to human testing of drugs and devices, but there are currently no clear federal regulations pertaining to innovative surgical procedures. Dr. Moreno will discuss the results of a study of experimental surgery by the University of Virginia Center for Biomedical Ethics and discuss they study's implications for national policy.
Following this lecture, participants should be able to:
- Describe how to determine when an innovative surgical procedure is research.
- Describe the attitudes and concerns of surgeons about innovative procedures, according to a national survey.