CAF Ethics Pharmacivigilance

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.

Prerequisites

Recommended: Prior completion of

• CAF600