Which items must the IRB/IEC promptly notify the investigator in writing?

• A. Its trial-related decisions/opinions
• B. The reasons for its decisions/opinions
• C. Procedures for appeal of its decisions/opinions
• D. All of the above

Answer: (D)

When an IRB/IEC reviews a study, it must communicate its decisions to the investigator in writing and do so promptly. The notice should include three things: the actual decision or opinion (for example, approval, approval with required changes, or disapproval), the reasons or rationale behind that decision, and the procedures available to appeal or request reconsideration. Providing the decision itself helps the investigator know what actions are required to move forward. Supplying the reasons clarifies exactly what must be addressed or changed, guiding a proper revised submission. Outlining the appeal procedures ensures the investigator has a clear, formal path to challenge or seek reconsideration if they disagree with the decision. Together, these elements support transparency, accountability, and the protection of participants, so all of these aspects must be communicated.