Basic principles for conducting human research in orthopaedic medicine.

Researchers and clinicians operate in an increasingly complex clinical and regulatory environment in which understanding the principles governing human research is essential. However, most orthopaedic surgeons have not received in-depth training in regulatory requirements and scientific research methods. Ensuring that research is conducted in accordance with state and federal laws and ethical principles is essential to guard compromising patient information and avoid severe penalties for noncompliance. The researcher must understand the regulations for compliance and proper data management, including the requirements of the Health Insurance Portability and Accountability Act, proper application of informed consent, use of the Institutional Review Board, and data protection guidelines. Tools such as a regulatory binder can assist investigators in complying with requirements, maintaining regulatory standards, and ensuring a robust study design and conduct.