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  4. Considering appeals from PIs

Considering appeals from PIs

PIs have an opportunity to appeal IRB decisions, such as not approving a proposed modification, or a finding of serious or continuing noncompliance. To do so, they draft a written appeal request and send it, along with any supporting documentation, to the IRB office, where staff then assign it to an agenda using the “office action” form. The appeal will be considered by a different committee than the one that made the original decision.

When reviewing and discussing appeals, it’s helpful for reviewers to consider whether the appeal includes any new information that wasn’t available when the first board made its decision. While it made be tempting to consider the longer-term consequences of either upholding the previous decision or changing it, the board considering the appeal should make its decision based on what believes is correct and supported by the available information. The chair can help answer questions about specific appeal items or about the process for reviewing appeals.

Posted by Edith Paal on January 15, 2015

Filed Under: Institutional Review Board Members

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