Compliance, Legal, and Regulatory Issues

3 units

This course will examine the legal framework governing clinical research with human subjects in the United States. An overview of the legal system including U.S. sources of law, the interplay between the federal and state systems and the role of case law, legislatures and regulatory agencies in shaping current law and policy will be provided. Federal and state law governing clinical research from proposal to completion will be examined. At the conclusion of this course, students will be able to identify the current sources of law, policy and persuasive authority in clinical research compliance. Students will also be able to identify areas of concern and potential new or amended regulation in clinical research.