Adverse Events reporting system at Kaiser Permanente: Promoting collaboration for the protection of human subjects

Background: Adverse event (AE) reporting to the Institutional Review Board (IRB) and, in some circumstances, Federal agencies, is required by Federal regulation. Kaiser Permanente Southern California (KPSC) implemented standard operating procedures (SOP) for the reporting of AEs to ensure that human subjects obtain necessary information to make an informed decision about their participation or continuation in a study. Our objectives are to: 1) discuss challenges in regulatory language interpretation and IRB review of AEs in federally regulated studies, 2) share strategies to train researchers to diminish confusion about regulatory reporting and 3) share processes for reporting and review to ensure compliance.

Methods: We reviewed all reported AEs to the KPSC IRB for 2005-2006 to identify new ways to improve institutional SOPs, investigator training and the use of the National Cancer Institute (NCI) Centralized Institutional Review Board (CIRB).

Results: Existing SOPs contained clearer terms that aided in reporting AEs in compliance with federal standards. The forms used and additional procedures indicated that investigators increased their knowledge on reporting AEs. The added use of the NCI CIRB increased further monitoring and oversight at multiple sites.

Conclusion: Investigator compliance with established SOPs for the reporting of AEs and use of the NCI CIRB suggests that these systems are pivotal in increasing compliance with the process required by Federal mandates. This collaborative approach comprising of the CIRB, investigators and support from institutional officials program-wide leads to sustaining a shared responsibility and culture of compliance for the protection of human subjects.