J Trauma
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Experimentation involving human subjects requires careful attention to the protection of their rights. Beginning with the Belmont Report in 1979, the United States has developed various sets of rules and regulations that identify the requirements for performing human subject research. In addition, these standards attempt to define the fundamental difference between what constitutes research versus clinical treatment versus innovation. We explore the intersection between two areas of independent bioethics, surgical innovation and emergency research; the point we refer to as emergency innovation. ⋯ For emergency innovation, where it is unclear what ethical principles and regulatory powers apply, it is imperative to be unambiguous about the purpose of the investigation, to adhere to all applicable ethical principles, and to have utmost consideration for protection of the research subject. To determine intent, the goals of the study must be outlined precisely - and if those include the prospect of publication, institutional review board (IRB) approval should be involved early. If, however, the innovation is subtle and the goal geared toward improved patient care, a small feasibility trial would be an appropriate first step before transitioning to a formal larger study approved by an IRB. In either case, the degree of the change in practice must be carefully evaluated and the vulnerability of the research subjects respected. With careful attention paid to all applicable ethical principles at the emergency innovation intersection, medical progress can continue at minimized risk to the human subject participants.