1. Adverse events reporting system at Kaiser Permanente: Promoting collaboration for the protection of human subjects Arthur Durazo IRB Administrator Kaiser Permanente Southern California

2. Learning Objectives Learning Objectives Discuss challenges faced by researchers and ethicists involved in creating a culture of safety.Discuss challenges faced by researchers and ethicists involved in creating a culture of safety.

3. Learning Objectives Learning Objectives Learn to develop standard operating procedures and shared systems for the proper reporting and auditing of adverse events to the federal agencies.Learn to develop standard operating procedures and shared systems for the proper reporting and auditing of adverse events to the federal agencies.

4. Learning Objectives Learning Objectives Recognize educational strategies for researchers to meet specific needs for patient safety and to protect the welfare, safety and health of research participants.Recognize educational strategies for researchers to meet specific needs for patient safety and to protect the welfare, safety and health of research participants.

5. Challenges Differences in terminology for adverse event (AE) versus an unanticipated problem (UP) among federal agenciesDifferences in terminology for adverse event (AE) versus an unanticipated problem (UP) among federal agencies

6. The KPSC Reporting Process The KPSC Reporting Process The KPSC IRB documents and reviews AEs and UPs occurring at KPSC sites in line with its existing standard operating procedures.The KPSC IRB documents and reviews AEs and UPs occurring at KPSC sites in line with its existing standard operating procedures.

7. The KPSC Reporting Process The KPSC Reporting Process KPSC researchers document the information required by DHHS/OHRP and FDA to submit reports of occurrences for IRB review to ensure compliance.KPSC researchers document the information required by DHHS/OHRP and FDA to submit reports of occurrences for IRB review to ensure compliance.

8. Case A laptop with human subjects’ Personal Health Information was stolen from the PI’s office. Included were names, dates of birth, medical record numbers and diagnosis. A laptop with human subjects’ Personal Health Information was stolen from the PI’s office. Included were names, dates of birth, medical record numbers and diagnosis.

9. Case Stolen laptop… Stolen laptop… Is this a UP and/or an AE? A protocol violation, deviation? Is this a UP and/or an AE? A protocol violation, deviation? How, when and to whom should this be reported? How, when and to whom should this be reported?

10. Self-Monitoring Activities In 2007, the KPSC IRB conducted a self-monitoring of its reporting processes to document UPs and AEs to: In 2007, the KPSC IRB conducted a self-monitoring of its reporting processes to document UPs and AEs to: Increase a “culture of conscience” with federal reporting guidelines, Increase a “culture of conscience” with federal reporting guidelines,

11. Self-Monitoring Activities … self-monitoring (continued): … self-monitoring (continued): Assess safety measures, Assess safety measures, Identify improvement needs, Identify improvement needs, Develop educational and mentoring opportunities. Develop educational and mentoring opportunities.

12. Methods Data was gathered retrospectively from existing reports of 243 AEs, SAEs and UPs submitted in 2005- 2006 by KPSC researchers. Data was gathered retrospectively from existing reports of 243 AEs, SAEs and UPs submitted in 2005- 2006 by KPSC researchers.

13. Results Findings showed: Findings showed: Researchers did not report UP and AEs within the time requirements according to existing KPSC standard operating procedures. Researchers did not report UP and AEs within the time requirements according to existing KPSC standard operating procedures.

14. Results Findings showed (continued): Findings showed (continued): Researchers were confused about to whom, how and when to report an UP versus an AE. Researchers were confused about to whom, how and when to report an UP versus an AE.

15. Results Findings showed (continued): Findings showed (continued): Existing procedures and forms to report UP and AE were not user- friendly and too stringent compared to the federal guidelines. Existing procedures and forms to report UP and AE were not user- friendly and too stringent compared to the federal guidelines.

16. Results Findings showed (continued): Findings showed (continued): Some UPs were not appropriately identified and reported to the institution and the federal agencies. Some UPs were not appropriately identified and reported to the institution and the federal agencies.

17. Conclusions Corrective action plans, educational and mentoring sessions advanced researchers understanding of the differences between AEs and UPs occurrences at KPSC sites. Corrective action plans, educational and mentoring sessions advanced researchers understanding of the differences between AEs and UPs occurrences at KPSC sites.

18. Conclusions Self-monitoring of AE s and UPs processes must be ongoing to comply with federal guidelines, improve safety measures and enhance reporting. Self-monitoring of AE s and UPs processes must be ongoing to comply with federal guidelines, improve safety measures and enhance reporting.

19. Conclusions The use of NCI’s* Central IRB increased monitoring and oversight and resulted in meeting compliance requirements by federal mandates. The use of NCI’s* Central IRB increased monitoring and oversight and resulted in meeting compliance requirements by federal mandates. * http://www.ncicirb.org/

20. Recommendations Continue self-monitoring efforts, including use of information systems such as iMedRIS to improve research participant safety. Continue self-monitoring efforts, including use of information systems such as iMedRIS to improve research participant safety.

21. Recommendations Increase mentoring opportunities to improve understanding and reporting of AEs and UPs. Increase mentoring opportunities to improve understanding and reporting of AEs and UPs.

22. Recommendations Continue to revise standard operating procedures to include new OHRP guidance recommendations towards a “culture of conscience.” Continue to revise standard operating procedures to include new OHRP guidance recommendations towards a “culture of conscience.”