When a research proposal is disapproved, or changes are required, the investigator may request a re-examination of the protocol by the IRB. The IRB should allow the investigator to present his/her case, in person or in writing, and should comply with subsequent requests for re-review if the investigator has made significant changes to the study or has significant new information to present. The IRB must assist in this process by supplying the investigator, in writing, with its reasons for disapproval or for requiring changes.
The local procedure manual should explain how appeals against decisions of the IRB are to be handled. The investigator should be given the opportunity to address the IRB and to provide additional references and/or consultants' reports which may support his/her case.
None of the above should be construed to require an IRB to hear trivial or frivolous appeals. However, every effort should be made by the IRB and the investigator to act in good faith to resolve disagreements.