Research Ethics in Regulatory Affairs

Catalog description

This course will focus on of the connection between biomedical research ethics and aspects of regulatory affairs. Students will apply frameworks for evaluating research ethics questions through the exploration of modern biomedical research topics. Students will cultivate competency in the application, and limitations, of US human subjects’ regulations. This course will prepare students to critically evaluate the ethics of specific research topics and apply ethics-informed decision-making in the regulatory affairs domain. Contemporary research ethics topics include (but are not limited to) research study recruitment, conflicts of interest, human research protection programs, informed consent, working with vulnerable populations, privacy/confidentiality, and emerging medical technology. The course will implement asynchronous videos and readings and interactive synchronous sessions; assignments include quizzes, discussions (in-class and online), and a generative final project.