The SMART IRB Agreement requires the Reviewing IRB to notify Relying Institutions of any findings and actions it makes with regard to “significant” subject complaints occurring at the Relying Institution or occurring at other institutions if the complaint or action could affect the rights and welfare of subjects at the Relying Institution.
A significant subject complaint is, generally, one that could affect the conduct of the Research. Examples might be a complaint that a subject was not provided sufficient time to read the consent form or that a blood draw occurred without informed consent. An example that would generally not rise to this level is if a subject complains about not receiving a promised parking voucher for a research visit or received the incorrect amount of study compensation. These are only examples, however, and the significance of a given complaint is to be determined by the Reviewing IRB in the context of the particular research study and other circumstances at issue.