Office for Human Research Protection (OHRP) and PRIM&R
This two-part program provides basic information on the topics of ethics in research and investigator compliance with federal regulations. Part 1 presents the history of research ethics and key ethical issues are explored in terms of application to research design and study execution. Regulatory compliance topics as they apply to investigators are presented in Part 2. Examined is the IRB approval process, obtaining informed consent, continuing review and proper study documentation and record retention practices.