What aspects of its own operations must the IRB/IEC establish and document?

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Understanding how an IRB/IEC operates is essential for protecting human subjects: it must have documented, written procedures that govern its own workflow. The best answer reflects that the IRB/IEC should establish and document its procedures overall, not just parts of its operations. This means detailing its composition (who serves, independence, qualifications), scheduling and conducting meetings (frequency, quorum, agenda, minutes), how reviews are conducted (submission, assessment, decision processes, criteria, expedited reviews), and how compliance is ensured (records, monitoring, handling noncompliance, regulatory adherence). Having these written procedures creates consistency, accountability, and regulatory alignment in every review. Documenting only the composition leaves gaps in how reviews are performed; documenting only meeting minutes captures events without the guiding framework; and not documenting procedures would undermine consistency and compliance.