SNMMI Clinical Trials Network Research Series for Technologists: Ethical Issues and Regulations in the Medical...

Ethical principles and laws have developed as medical practice and research have grown. This article discusses regulatory policies in patient care and the governing bodies that provide oversight. These include but are not limited to the Food and Drug Administration, Office for Human Research Protection, Code of Federal Regulations, Nuclear Regulatory Commission, Joint Commission, Health Insurance Portability and Accountability Act, Occupational Safety and Health Administration, World Health Organization, and International Conference on Harmonization. This article reviews ethical requirements in clinical research and provides examples of medical mistreatment that forced the development of these rules and regulations. Some include the Nuremberg Code, Declaration of Helsinki, and Belmont Report; good clinical practice; and the Common Rule. Several specific research documents are discussed further in this continuing education series. These guiding documents and principles are important because every patient and research subject deserves a safe environment with safe products and protection of privacy. Individuals deserve to understand their role in medicine and clinical research, have the right to refuse care, make informed decisions, know the risks and benefits included, and ultimately have their individual choices respected.