What must be included in informing the subject about the trial?

• A. Only the purpose of the trial will be explained.
• B. The elements to be communicated include the written information and IRB/IEC favorable opinion.
• C. The trial procedures and potential risks will be explained.
• D. All pertinent aspects including the written information and IRB/IEC favorable opinion will be provided.

Answer: (D)

Informed consent means giving the subject a complete, understandable set of information about the trial so they can decide whether to participate. This includes the written information (the consent form) and the fact that it has received IRB/IEC favorable opinion. You must explain all details a reasonable person would need to know: the purpose, the procedures, the potential risks and benefits, alternatives, confidentiality, compensation for injury, and who to contact, plus the voluntary nature and the right to withdraw at any time. Providing both the approved written information and the IRB/IEC approval status ensures ethical oversight is transparent and that no essential element is left out, which is why this option is the correct one.