Human Subject Protection: A Refresher Course

Learning Objectives:

• Define unethical conduct in clinical research

• Define ethical tensions in clinical research

• Explain the difference between fraud and misconduct

• Explain how ethical guidelines became mandatory in clinical research

• Identify the benefits of adhering to ethical principals

• Recognize the impacts and consequences of unethical conduct in clinical trials

• List measures to prevent unethical conduct

• Discuss how to approach suspected fraud or misconduct

Primary: All Clinical Research Personnel
Secondary: All Clinical Research Personnel

Knowledge level (basic, intermediate, advanced): Basic to intermediate

Competency: Related to the following Core Competencies:

Ethical and Participant Safety Considerations
Clinical Trial Operations (GCPs)
Scientific Concepts and Research Design

Activities Included:

Human Subject Protection: A Refresher Course