The SMART IRB Agreement requires Relying Institutions to report any significant subject complaints to the Reviewing IRB. What constitutes a significant subject complaint?

A significant subject complaint is one that cannot be resolved by the study team and suggests an increased or unexpected new risk/harm or a change to the risk/benefit ratio of the Research. Note that the SMART IRB Agreement requires Relying Sites to follow the policies of the Reviewing IRB. Thus, if the Reviewing IRB requires that all subject complaints be reported to that committee, the Relying Institution would need to comply with this requirement.