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Although research on drugs and medical devices for human is well regulated and scrutinized through the existing IRB system, there is a need for a careful review of the current process for approving surgical procedures involving new medical devices. In particular, the clinical application of innovative surgical procedures with new or existing devices should be examined from an ethical point of view. There are, at this point, no formal ethical rules concerning innovative surgical procedures, and important terms are in need of clarification and definition. This article argues that while the adequacy of IRB process for surgical innovation has to be reviewed, there are needs to debate on some reasonable and valid definitions and ethical regulations of surgical innovation. In addition to, while the potential of professional surgical organizations for self-regulation has to be respected, the debates concerning the ethical issues associated with innovative surgical procedures should be opened up to the academic medical sector and those outside of the medical community.