Ethical consideration in orthopedic research

Abstract

Concern for the ethics of human subject research has existed since the earliest days of scientific discovery. Respect for a participant's well-being and autonomy is of utmost importance. From this early understanding of patient autonomy, further principles emerged, and in the modern era, this was further accelerated and formalized, particularly after revelation of atrocities committed by Nazi "scientists." This leads to documents like the Nuremberg Code, the Declaration of Helsinki, and the Belmont Report, the formation of institutional review boards, and legislation passed by multiple legislatures, all in order to help ensure researchers abide by guiding principles of ethics. Specific to orthopedic surgery, there has been rising concern for conflict of interest due to the role of industry funding. The goals of this chapter are the following: Understand the historical basis for the development of regulations and governing bodies reviewing human subject research. Identify and understand ethical principles that guide human subject research. Understand how to navigate the current regulatory environment for human subject research.