During participation, what must be provided to the subject regarding consent updates?

• A. A copy of the updated consent form only
• B. A copy of amendments to the written information only
• C. A copy of both the updated consent form and amendments to the written information
• D. An oral summary

Answer: (C)

When consent is updated, the subject must receive a copy of the updated consent form and a copy of the amendments to the written information. This ensures they have the current terms and all new details in writing, so they can review and decide whether to continue. An oral summary or providing only one document wouldn’t give them a complete, durable record of what changed, which is essential for ongoing informed consent and regulatory compliance.