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.


Online Graduate Programs | Open House - October 22, 2016

Learn more about our programs.

compliance training and education
Health Law Publications