Which statement best describes how an IRB/IEC should operate?

Which statement best describes how an IRB/IEC should operate?

• A. May operate without written procedures or minutes
• B. May operate informally without following GCP
• C. Must maintain written records but not necessarily comply with regulatory requirements
• D. Should operate according to written operating procedures, maintain written records of activities and minutes, and comply with GCP and applicable regulatory requirements

Answer: (D)

IRBs/IECs operate with formal governance: they follow written operating procedures, keep written records of their activities and meeting minutes, and must comply with GCP and applicable regulatory requirements. This structure ensures consistency, accountability, and traceability in ethical review and oversight of research, protecting human subjects and supporting auditing or inspection. Choosing options that skip formal procedures or minutes would lead to ad hoc decisions and a lack of accountability, while informal operation without aligning to GCP undermines subject protection and proper documentation. Even if records are kept, failing to comply with regulatory requirements undermines legality and ethical standards. The correct approach—written SOPs, documented activities and minutes, and full compliance with GCP and regulations—embodies proper IRB/IEC governance.

IRBs/IECs operate with formal governance: they follow written operating procedures, keep written records of their activities and meeting minutes, and must comply with GCP and applicable regulatory requirements. This structure ensures consistency, accountability, and traceability in ethical review and oversight of research, protecting human subjects and supporting auditing or inspection.

Choosing options that skip formal procedures or minutes would lead to ad hoc decisions and a lack of accountability, while informal operation without aligning to GCP undermines subject protection and proper documentation. Even if records are kept, failing to comply with regulatory requirements undermines legality and ethical standards. The correct approach—written SOPs, documented activities and minutes, and full compliance with GCP and regulations—embodies proper IRB/IEC governance.