Policy Issue
Our institution’s SAE policy broadly defines the types of events to be submitted for IRB review. Analysis of this policy was conducted to gain perspective of its implementation over a three-year period.
Program Description
Federal regulations require reports for events that are serious and unexpected. SAEs include death, suicide attempts, hospitalizations, and adverse drug reactions. Our research subjects are vulnerable by virtue of mental illness. Consequently, our institution’s SAE policy casts a wider net by requiring serious or unexpected events to be reported. The vast majority of the SAEs reviewed by our IRB are categorized as serious and expected.
A review of the last three years’ SAE submissions (2012 to 2014) includes: 1) events based on severity and if it was study related; 2) if the event occurred onsite at our institution or at another site not under our jurisdiction as part of a multi-site trial (offsite); and 3) if it resulted in changes to study procedures or consent forms (CFs). A total of 285 SAEs from 132 studies were reviewed from 2012-2014. None of the SAEs reported in 2012 or 2014 were unexpected and related or possibly related to the study. In 2013, three SAEs that occurred onsite at our institution out of 111 SAEs reported were unexpected and related or possibly related to the study. Of these 285 SAEs, 5.6% resulted in changes to the protocol summary form or consent forms. The investigator proposed changes 50% of the time. The other 50% of the changes were stipulated by the IRB, referred to as IRB-initiated changes. IRB-initiated changes warrant scrutiny because serious and expected SAEs are reported to the IRB as a direct result of the institution’s broad reporting policy. Consequently, IRB-initiated changes would not have occurred without this policy.
Future Program Usage
Our SAE policy casts a wider net than federal regulations require because of the vulnerability of our institution’s populations. The IRB-initiated changes made to protocols are a small percentage (2.8%) of the overall SAEs reported, suggesting that casting a wider net may not have the impact the policy originally expected. Of note, close to half of IRB-initiated changes are for SAEs that occurred offsite. The sites where those SAEs occurred were not under our IRB’s jurisdiction but rather part of a multi-site trial, suggesting that our policy may encroach on other IRBs’ review of the same event.
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