What must be included in the written communication of IRB/IEC decisions after review?

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When the IRB/IEC communicates its decision in writing, it must include three elements: the decision itself, the reasons for that decision, and the procedures for appealing or seeking reconsideration. This combination ensures clarity and fairness. The decision alone tells you what happened, but the reasons explain the specific concerns or criteria that led to that outcome, guiding investigators on what must be addressed. Including the appeal or reconsideration process provides a clear path for due process if the investigator believes the decision should be reviewed, which supports fair treatment and helps protect participant safety and study integrity. In practice, this means the written notice should spell out what was decided, articulate why, and outline how an appeal can be filed. Providing only the decision or omitting the rationale or appeal steps would leave investigators unsure how to proceed or challenge the decision appropriately.