IRB/IEC procedures should be...

• A. Established, documented in writing, and followed.
• B. Informal and unwritten.
• C. Initiated only after enrollment begins.
• D. Kept confidential and not shared.

Answer: (A)

IRB/IEC oversight relies on clearly established and documented procedures that are consistently followed to protect participants and meet regulatory requirements. When procedures are written, they define how reviews are conducted, approvals granted, continuing oversight, adverse event reporting, informed consent processes, and confidentiality and data handling. This written framework ensures everyone on the study team knows the exact steps, supports consistency across reviews, and provides a traceable record for audits and regulatory inspections. Informal or unwritten processes lead to inconsistent decisions and accountability gaps. Initiating procedures only after enrollment begins would leave participants unprotected during the critical early phase and undermine oversight. Keeping information confidential and not shared conflicts with the need to communicate findings, approvals, and obligations to investigators, sponsors, and regulators.