Violations Submissions via Protocol Information Management System-Phase II


Description of the Research
In 2013, our center's IRB/Privacy Board (PB) transformed the process for submitting violations that enabled research staff to enter all violations into the Protocol Information Management System (PIMS). This change was implemented in an effort to increase efficiency of IRB/PB office processing procedures, to standardize the information being received, and to allow for tracking of data on the type of violations occurring at our institution. 

Prior to 2013, violations were submitted as memorandums signed by the principal investigators (PIs) and emailed to the IRB/PB. After receipt, these memos were pre-reviewed, forwarded to the IRB/PB chair for review, and then manually stamped received and provided back to the research staff for filing. The accepted memo was also uploaded into PIMS for documentation purposes. The content of the memos were often inconsistent and provided little data to evaluate trends or areas of concern.

Since 2013, violations have been submitted via the PIMS electronic form. While the flow from research staff to IRB/PB chair remains the same, the submission process has moved entirely to PIMS. This form has provided standardization of the incident and data types.

The use of this electronic submission via PIMS has created a database in which useful data is collected including: IRB/PB protocol number, PI, department/service, date of violation submission, participant MRN number, date of violation event, location, violation category, corrective action plan, participant injury due to the violation, and if there is follow-up required from the IRB/PB and/or the PI. The IRB/PB office has been able to analyze this data in a meaningful way and produces an annual Protocol Violation Summary. These reports help to identify trends in the types of violations that are occurring, inform which areas require future initiatives directed at reducing violations, and allow the IRB/PB Office to tailor the PIMS violation form in a manner consistent with the demands of reporting.