RSA - 514 Legal, Ethical and Regulatory Compliance

This course introduces students to legal, ethical and regulatory issues encountered in monitoring, implementing and managing research projects. Students will learn to apply ethical principles and legal and regulatory requirements to develop compliance programs, monitor investigator and institutional compliance, and implement corrective action. Students will learn how to design and implement a compliance program, processes for monitoring compliance and how to apply appropriate principles and processes to correcting noncompliance. The primary emphasis of the course will be on fundamental issues involved in structuring compliance programs that conform to legal requirements as well as principles of scientific integrity. Prerequisite: Admission to the program. Credit Hours: (4)