Why does the SMART IRB Agreement require Site Investigators to notify the Reviewing IRB of any subject complaints and any subject injuries?

Although complaints and injuries are not per se reportable events unless they also meet the definition of an unanticipated problem involving risks to subjects or others (or otherwise occur in connection with another reportable activity), some reliance agreements specifically require complaints and injuries to be reported to the IRB in the first instance to make sure that there is an independent judgment (other than the investigator’s or relying institution’s) as to whether they constitute unanticipated problems. In other words, some institutions view injuries, in particular, as inherently significant such that the reviewing IRB should be informed and have the opportunity to determine whether further reporting is required. Whereas these judgments might be made entirely by investigators when the IRB is internal to the institution conducting the research, in the reliance context the IRB is not as familiar with the standards and norms of the investigators or the relying institution, and all significant complaints, research-related injuries, and other events are to be reported to the Reviewing IRB. Note that the Agreement limits subject complaints that require reporting to those that are “significant” (see above for a definition of “significant”) and injuries must be related to the research in order to require reporting to the Reviewing IRB.