Researchers may request that the IRB reconsider a decision by submitting a written response to the IRB. When submitting a request to reconsider, the researcher must provide rationale for the request, including any additional supporting documents.

Grounds for a request are limited to:

• New information not reasonably available during the IRB review/investigation
• Material failure by the IRB to follow IRB policies and procedures
• The sanction exceeds the severity of the noncompliance violations, if applicable
• The action is disproportionate to the risks to subjects safety/welfare

These considerations also apply to all other submissions, including changes, continuing reviews, reportable events, and also where the IRB has suspended or terminated the research.