Which item describes the known and potential risks and benefits to human subjects?

• A. A summary of known and potential risks and benefits to human subjects
• B. Description of and justification for route of administration
• C. Name and address of the physician
• D. References to literature and data

Answer: (A)

Informed consent requires that participants receive a clear summary of what is known and what is potential about the risks and benefits of joining the study. The item that directly communicates this information is the summary of known and potential risks and benefits to human subjects. It lets participants weigh possible harms against potential gains and understand the likelihood and seriousness of those outcomes in plain language, which is essential for voluntary and informed participation under ICH-GCP.

Other elements like how the treatment is administered, the physician’s contact details, or references to literature support the study in other ways, but they do not provide the necessary risk-and-benefit information that enables a participant to make an informed decision.