Human Subjects Protection
This course will cover the law of protecting human subjects in clinical research. Federal agencies require institutions conducting research to have a study approved by an Institutional Review Board (IRB), obtain informed consent from the human subject, and self-disclose to the government various events. The course will review the regulations governing IRBs, the content of informed consent forms, the monitoring of research studies, and the disclosure of unanticipated events and significant non-compliance. The course will look at enforcement cases as well as tort liability. Financial relationships between investigators and sponsors will also be covered. LAW 958 (Life Sciences, Research and the FDA) is a preferred prerequisite but is not required.