Introducing new technologies: protecting subjects of surgical innovation and research.

The system for protecting human research subjects is under increasing pressure. Under the currently dominant Regulatory Ethics Paradigm, clinical research protocols must be reviewed and approved by an institutional review board (IRB) or equivalent. Although the IRB was introduced into health care in part to protect patients and investigators from the inherent conflict between the best clinical interest of the individual patient and the interest of science and society in answering a clinical question, its rigorous standards and rigid framework discourage surgeons from seeking potentially valuable early IRB consultation. Most of the important advances in the history of medicine, such as anesthesia, appendectomy, antibiotics, intensive care, and immunization, were introduced through an informal, unregulated innovation process that has been enormously productive but can lead to ratification of ineffective or harmful treatment by credulous physicians and patients. We propose a surgical innovation ethics paradigm that is a more nimble, flexible source of institutional and public oversight and approval of innovations that are in the gray zone prior to their conversion to formal protocols that then require IRB approval. We also discuss the management of personal and institutional conflicts of interest.