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CAF621 CAF Ethics & Pharmacivigilance

Lead Faculty: Irvin Kluth

Course Description

This course identifies and describes the background and history for the protection of human subjects in clinical research. It also provides the student with a solid understanding of the ethical principles and practical challenges associated with protecting human subjects in clinical research. Students will identify and discuss ethics as a discipline, the Declaration of Helsinki, Institutional Review Boards, Informed Consent Forms, Data Management Committees/Data Monitoring Boards, Compliance, and HIPAA.

Learning Outcomes

  • Contrast the key trends in establishing the ethical environment in which we live.
  • Examine the regulatory and ethical basis for the protection of human subjects and clinical trial safety monitoring.
  • Argue the framework of the Declaration of Helsinki.
  • Evaluate and judge the responsibilities and function of Institutional Review Boards (IRBs) and Independent Ethics Committees (IECs).
  • Defend the contribution of informed consent and clinical trial safety monitoring to the protection of human subjects in clinical trials and in clinical research.