Ethical Considerations in Orthopaedic Research

Concern regarding the ethics of human subject research has existed since the earliest days of scientific discovery. However, the formalization of research ethics was accelerated following the revelation of atrocities committed by Nazi “scientists.” In order to help ensure researchers abide by guiding principles of ethical research, documents like the Nuremberg Code, Belmont Report, the Declaration of Helsinki, as well as the formation of institutional review boards, were instituted. Respect for a participant’s well-being and autonomy is of utmost importance. There is rising concern, specific to orthopaedic surgery, over conflict-of-interest secondary to the role of industry funding in orthopaedic research. The goals of this chapter are the following: (1) Discuss the basis of development of governing bodies and regulations reviewing human subject research; (2) Review the ethical principles that guide human subject research; and (3) Understand how to navigate current regulations regarding human subject research.