When should the written informed consent form and any other written information be revised, and what approval is required before use?

• A. Whenever important new information becomes available that may be relevant to the subject's consent, and the revised written informed consent form and written information should receive the IRB/IEC's approval/favorable opinion in advance of use. The subject should be informed in a timely manner if new information becomes available, and the communication should be documented.
• B. Never revise the consent form.
• C. Only at the sponsor's discretion.
• D. Revisions require only investigator approval.

Answer: (A)

The main idea is that consent documents must be updated whenever important new information arises that could affect a participant’s decision to enroll or stay in the study. Before any revised written informed consent form or written information is used with participants, it must receive the IRB/IEC’s approval or favorable opinion. If new information becomes available, participants must be informed in a timely manner, and the communication should be documented to show they were updated about risks, procedures, or alternatives.

This reflects the ongoing nature of informed consent and the role of ethical oversight. Revisions cannot be implemented solely at the sponsor’s or investigator’s discretion; they require IRB/IEC approval to protect participants. And you don’t wait for updates to use them; you must inform subjects promptly when new information could influence their participation.