Overview
Syllabus
Intro
Clinical Research
The First Clinical Trial?
Virtues
Concerns
Conflicts of Interest
National Commission
Challenges
Benefits and Risks
Primary Ethical Concern
Regulations and Guidelines
Comparison
8 Ethical Requirements
Collaborative Partnership
Social Value
#2: Evaluation
Scientific Validity
Clinical Equipoise
Assessment
Exceptions
Fair Subject Selection
Protection to Access
Favorable Risk-Benefit Ratio.
Independent Review
Informed Consent
Waiver
Incompetent Participants?
Therapeutic Misconception
Respect for Subjects
Resolving Conflicts
Problems
Rebirth of the Integrated Model?
Application to LHC
SUPPORT Trial
Research and/or Care?
Summary
Taught by
NIH Clinical Center