Institutional Review Board (IRB)/Independent Ethics Committee (IEC) Approval: Include information about the IRB/IEC, confirming that its composition and mechanism for provision of approval are consistent with International Conference on Harmonization, Food and Drug Administration (FDA) Code of Federal Regulations (CFR), and/or local and regional requirements and that all necessary IRB/IEC approval and Competent Authority approvals will be obtained in connection with the proposed research.