Which item is NOT a required element of IRB/IEC confirmation of review?

Which item is NOT a required element of IRB/IEC confirmation of review?

• A. The name and address of IRB/IEC
• B. A statement from IRB/IEC that it operates according to GCP and applicable laws
• C. Documented IRB/IEC approval/favorable opinion and copies of protocol and consent
• D. The sponsor's financial statement

Answer: (D)

The main idea here is what the ethics review confirmation must show to prove that proper IRB/IEC review occurred and was compliant with GCP and laws. A valid confirmation should identify the reviewing body (name and address), include a statement that the IRB/IEC operates in accordance with GCP and applicable laws, and provide evidence of the actual review outcome—typically the approved or favorable opinion with the date and any conditions—along with copies of the protocol and consent documents that were reviewed. The sponsor’s financial statement isn’t connected to the ethical review, rights protection, or regulatory compliance aspects of the study, so it isn’t a required element in the confirmation of review.

The main idea here is what the ethics review confirmation must show to prove that proper IRB/IEC review occurred and was compliant with GCP and laws. A valid confirmation should identify the reviewing body (name and address), include a statement that the IRB/IEC operates in accordance with GCP and applicable laws, and provide evidence of the actual review outcome—typically the approved or favorable opinion with the date and any conditions—along with copies of the protocol and consent documents that were reviewed. The sponsor’s financial statement isn’t connected to the ethical review, rights protection, or regulatory compliance aspects of the study, so it isn’t a required element in the confirmation of review.