What consent form must be used?

• A. The version agreed upon by the sponsor
• B. The earliest version used in the study
• C. A copy of the signed assent form
• D. Current IRB-approved version

Answer: (D)

Informed consent must use the version of the consent form that has current IRB approval at the time participants are enrolled. The IRB approves the form after reviewing its content, including all required disclosures and protections for participants. If the study makes changes to risks, procedures, or other information, a new IRB-approved version must be used, and participants may need to be re-consented. Using a sponsor’s version or an earliest version risks providing outdated or incomplete information and can violate regulatory requirements. A signed assent form is related to minors and, while important, does not replace the standard consent form that the IRB must approve and that governs adult participation. Therefore, the current IRB-approved version is the one that must be used.