Which document would you reference to verify the IRB/IEC approval status and its date/version information?

Which document would you reference to verify the IRB/IEC approval status and its date/version information?

• A. IRB/IEC Composition
• B. Curriculum Vitae and/or Other Relevant Documents Evidencing Qualifications of Investigators and Sub-Investigators
• C. Sample of Labels Attached to Investigational Product Containers
• D. Dated, Documented Approval/Favorable Opinion of IRB/IEC

Answer: (D)

Verifying IRB/IEC approval status requires a formal record that the committee has reviewed the study and given its consent to proceed, including when and under which version of the protocol and consent materials approval was granted. The document that provides this is the dated, documented approval/favorable opinion of IRB/IEC. It clearly shows the approval date and the specific version of the protocol (and often consent forms) that was approved, which is essential to confirm that the study is running under an approved, current framework. Other documents don’t serve this purpose: IRB/IEC Composition shows who sits on the board, not whether approval was granted or when; Curriculum Vitae or qualifications show who is involved but not the study’s approval status; samples of labels relate to packaging and labeling compliance, not ethical approval.

Verifying IRB/IEC approval status requires a formal record that the committee has reviewed the study and given its consent to proceed, including when and under which version of the protocol and consent materials approval was granted. The document that provides this is the dated, documented approval/favorable opinion of IRB/IEC. It clearly shows the approval date and the specific version of the protocol (and often consent forms) that was approved, which is essential to confirm that the study is running under an approved, current framework.

Other documents don’t serve this purpose: IRB/IEC Composition shows who sits on the board, not whether approval was granted or when; Curriculum Vitae or qualifications show who is involved but not the study’s approval status; samples of labels relate to packaging and labeling compliance, not ethical approval.