What information should participants be provided about how long they are expected to participate?

• A. The expected duration of their participation.
• B. The total duration of the entire trial globally.
• C. The duration of the consent process only.
• D. The duration is not specified.

Answer: (A)

When obtaining informed consent, you must tell participants how long they’re expected to participate. Providing the approximate duration from enrollment to the final follow-up helps them assess whether they can commit, plan their time, and understand the burden of participation. The consent should describe the time commitment, including the number of visits and procedures anticipated, and note that the actual duration might vary if they withdraw early or if the study requires longer safety follow-up. If there’s any potential variability, give a range and explain factors that could shorten or extend participation. Saying the total global trial length isn’t necessary for the individual’s decision, and describing only the consent process duration misses the important time commitment they are agreeing to. And stating that the duration isn’t specified would deprive participants of essential information needed to make an informed choice.