Clinical Research and the Law

Division of Online Learning

  • HIPAA compliance
  • IRB
  • conflicts of interest
  • OHRP
  • FDA
  • undue inducement
  • certificates of confidentiality
  • NIH
  • informed consent
  • Common Rule
  • CRO
  • DSMB

Learn to:

  1. Navigate the maze of regulatory requirements applicable to clinical research with human participants

  2. Evaluate proposed research projects to determine whether they meet the criteria for institutional review board (IRB) approval

  3. 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.

Master of Science in Jurisprudence Online Degree | Open House - October 24, 2015

Health Reform Watch
Health Law Publications
compliance training and education