Ethical Issues in Surgical Research

All biomedical research, including clinical medical and surgical research, should conform to a set of ethical principles first delineated in the Nuremburg Code, and subsequently expanded upon in the Belmont and Helsinki Reports. Despite this agreement on principles of human subjects' research in the medical field, there is a lack of clarity about special aspects of surgical research ethics when compared with medical research ethics. Because of the unique relationship between the surgeon and his/her patient, which includes extraordinary proximity and a degree of physical violence, many regard surgical ethics as a unique entity. We define surgical research ethics as research that involves actual procedures and/or operations. The spe-cific ethical issues in surgical research that we discuss are randomized controlled trials, placebo surgery, and surgical innovation and its regulation. Strategies for the adaptation to new cultural norms and expectations are also discussed.