What should an informed consent document describe?

• A. details about purpose, duration, procedures, risks, benefits and key contacts
• B. the sponsor's financial information
• C. only the study's goals
• D. a marketing plan

Answer: (A)

The key idea is that an informed consent document must give a participant clear, study-specific information to make a voluntary, informed decision about joining. It should describe what the study involves, including the purpose, how long it will last, and what procedures or activities are required. It also needs to outline potential risks and benefits, and who to contact with questions or concerns. This combination helps a person understand what participation means and who to reach if issues arise, supporting an autonomous choice.

The sponsor’s financial information isn’t needed to decide about participation, and a marketing plan has no relevance to the participant’s decision. Merely listing the study goals without detailing procedures, risks, or contacts leaves a person unable to assess what participation would entail.