The Association of Clinical Research Professionals

Ethical Foundations in Clinical Trials: A Refresher with ICH E6(R3) Guidance 

Building on core ethical principles, this course shifts the focus from theory to practice—exploring how ethical conduct plays out in real-world scenarios.

This refresher course is designed for clinical research professionals who have completed the foundational training, Ethics and Human Subject Protection: An Introduction with ICH E6(R3) Guidance.

Through case-based examples and practical insights, participants will visit key concepts such as ethical tensions, misconduct, and fraud, while gaining a deeper understanding of how to recognize and respond to ethical challenges in the field.

The course also reinforces the importance of adhering to ethical guidelines and highlights the consequences of unethical behavior—not just for trial outcomes, but for public trust and professional credibility.

This course supports continued competency in Clinical Trials Operations (GCPs), Ethical and Patient Safety Considerations, and Scientific Concepts and Research Design, helping professionals stay sharp, informed, and ethically grounded in their day-to-day work.​

At the end of this course, participants should be able to:

  • Reaffirm your understanding of key ethical concepts and tensions in clinical research.
  • ​Distinguish between fraud, misconduct, and unethical behavior with greater nuance.
  • ​Reflect on the historical development and evolution of ethical guidelines in clinical research.
  • ​Revisit major ethical codes and regulations, including updates in ICH E6(R3).
  • ​Evaluate the benefits of adhering to ethical principles in complex or ambiguous scenarios.
  • ​Analyze the consequences of unethical conduct for individuals, institutions, and public trust.
  • ​Apply strategies and safeguards to prevent unethical conduct in real-world clinical settings.
  • ​Demonstrate appropriate responses to suspected fraud or misconduct, aligned with current regulatory expectations.​

Approved for 1.5 ACRP Contact Hours | Available 1 Year from Enrollment Date