Navigate the maze of regulatory requirements applicable to clinical research with human participants
Evaluate proposed research projects to determine whether they meet the criteria for institutional review board (IRB) approval
Analyze proposed regulatory changes and assess their potential impact on researchers, research subjects, institutions, and sponsors
This clinical research class immerses students in the federal laws, regulations, and policies applicable to clinical research with human participants, including the Common Rule, the FDA protection of human subjects, the HIPAA Privacy Rule, and NIH and FDA policies on conflicts of interest, informed consent in research and the inclusion of women and minorities in clinical research. Online discussions and practical exercises allow students to apply newly-acquired knowledge to real-world situations. Upon completion of the course, students will have a broad understanding of the legal and ethical framework of clinical research from multiple points of view.