
Assessing Comprehension of Key Concepts: Randomization, Placebo, Voluntariness
Provides targeted comprehension assessment strategies for the four most commonly misunderstood consent concepts: randomization, placebo, voluntary withdrawal, and confidentiality.
Four concepts, four failure points
Ask a participant to explain randomization, and you will hear something like: "My doctor will choose the best treatment for me." Ask about the placebo arm, and: "That means I would not get any treatment at all." Ask about withdrawal, and: "I know I can quit, but I would not want to let the team down." Ask about confidentiality, and: "Nobody except my doctor will ever see my records."