What is a key outcome of having documented operating procedures for the IRB/IEC?

• A. They increase recruitment speed without regard to safety
• B. They replace need for ethics review
• C. They are optional in most trials
• D. They help perform functions effectively and maintain regulatory compliance

Answer: (D)

Documented operating procedures provide a standardized framework for IRB/IEC functions, ensuring consistent decision-making and regulatory compliance. When an IRB/IEC has clear SOPs, every step—from initial submission review to continuing review, changes to protocols, adverse event handling, informed consent processes, and record-keeping—is defined. This clarity helps members perform their roles efficiently, reduces variability in how reviews are conducted, and creates an auditable trail that supports inspections and regulatory requirements. In short, SOPs align the committee’s activities with applicable laws and good clinical practice, safeguarding participant rights and data while promoting quality and accountability.

The other statements aren’t correct because SOPs do not speed recruitment at the expense of safety, they do not replace the need for ethics review, and they are not optional in trials; they are foundational to the IRB/IEC’s proper operation and regulatory adherence.