Which element is typically included in an informed consent document?

• A. details about purpose, duration, procedures, risks, benefits and key contacts
• B. the sponsor's private financial disclosures
• C. a marketing summary
• D. results of the trial

Answer: (A)

The key idea being tested is what information must be provided to someone when they are asked to participate in a study. An informed consent document should clearly spell out the study’s purpose, what will be done (the procedures), how long the study will take (duration), the potential risks and benefits, and who to contact with questions or concerns. This combination gives the participant enough factual detail to decide whether joining the study aligns with their values and needs, and it also provides a clear route for support or reporting issues.

Details about the sponsor’s private financial disclosures aren’t part of what participants need to decide about joining a study; those are conflict‑of‑interest disclosures intended for oversight bodies, not for informing a participant’s decision. A marketing summary isn’t appropriate because it could be biased or promotional, whereas the consent form should present balanced, neutral information. The results of the trial aren’t included in the consent document because participants are not being asked to decide based on trial outcomes that may not be known yet, and results are typically communicated after the study through separate channels.

So, the element that belongs in an informed consent document is the description of the purpose, duration, procedures, risks, benefits, and who to contact for questions.