During participation, what must be provided to the subject when updates to consent are made?

• A. Only the original consent form
• B. Only amendments to written information
• C. Both the signed and dated consent form updates and copies of amendments to the written information
• D. No notification is required

Answer: (C)

Consent is an ongoing process, and any new information that could affect a subject’s willingness to participate must be communicated clearly. When updates to consent are made, you must provide the subject with the updated consent documentation in a way that they can review, understand, and formally agree to continue participation. This means giving them the updated consent form that is signed and dated, along with copies of the amendments to the written information that describe the changes. This ensures the subject has both a current, signed record and a clear understanding of what changed.

Providing only the original consent form would not reflect the new information, and giving only the amendments without a signed, updated consent form would not establish updated, documented consent. No notification is not acceptable because participants must be informed of changes that affect their participation.