Ethics Considerations and Approval in Human Research and Orthopedics

Ethical approval provides public assurance that the rights, safety, and well-being of trial subjects are protected. This has become a mandatory step in the conduct of clinical trials involving human subjects. Ethical approval is currently required by academic research administration, government regulatory bodies, and peer-reviewed journals as a condition of study initiation, conduct, and publication. Ethics in research must, however, not be limited to the study itself. Investigators should also always follow the fundamental principles of research integrity and prevent unacceptable practices in research such as fabrication, falsification, plagiarism, and research misconduct. This chapter is designed to discuss a large range of ethical issues with a specific focus on orthopedic research. The aim is to increase the awareness of the reader on several major ethical issues that might arise when undertaking clinical research.