CUMC IRB Investigator Meeting Status of the IRB January 18, 2005

1. CUMC IRB Investigator MeetingStatus of the IRBJanuary 18, 2005

2. Objectives • This presentation will provide information on: • Challenges facing the IRB • Statistics on IRB Performance in 2004 • Changes during the past year • Solutions/Plans to Improve IRB Quality and Performance

3. Challenges Facing the IRB • High volume of submissions • Regulatory requirements • Addressing past noncompliance issues • Staffing issues • RASCAL • IRB members – Broaden expertise

4. 2004 – IRB volume measured by submissions

5. 2004 Staffing levels of the IRB adjusted for leave

6. 2004 Total approvals by CU/CUMC IRBs

7. 2004 Total approvals by CU/CUMC IRBs

8. Individual IRB Performance – Turnaround TimeExpedited Review

9. Individual IRB Performance – Turnaround TimeFull Board Review

10. Individual IRB Performance – Turnaround TimeExpedited Review

11. Individual IRB Performance – Turnaround TimeFull Board Review

12. Individual IRB Performance – Turnaround TimeExpedited Review

13. Individual IRB Performance – Turnaround TimeFull Board Review

14. Individual IRB Performance – Turnaround TimeExpedited Review

15. Individual IRB Performance – Turnaround TimeFull Board Review

16. Individual IRB Performance – Turnaround TimeExpedited Review2004 Days IRB # From Days Days Studies Subm. To w/ w/ # Approval IRB PI Returns IRBs are coded to maintain confidentiality Total of 48 studies

17. Individual IRB Performance – Turnaround TimeFull Boards Review2004 Days IRB # From Days Days Studies Subm. To w/ w/ # Approval IRB PI Returns IRBs are coded to maintain confidentiality Total of 48 studies

18. Factors affecting data on IRB delays • Possible causes from the IRB: • Waiting for Cancer Cmte. approval • Waiting for IBC approval • Reviewer delay (Need for more members) • Need to obtain consultant/consultant’s review • Volume at next available IRB meeting resulting in study scheduled on following meeting’s agenda

19. Factors affecting data on IRB delays • 2) Possible causes from the Investigator: • Waiting for approval of changes or updated documentation from the sponsor • Waiting for documentation/action from FDA or other external agency • Waiting for resolution of contract or other funding matters

20. Possible causes of delays • Investigator causes of delays: • Resubmitting a protocol without addressing all requests/concerns • Timeliness of renewal submissions • Lack of clarity of Rascal functions • Missing documentation for protocols reviewed under an authorization agreement • Attaching documents that the IRB cannot approve; not archiving documents that have been replaced • Attaching files in a format that cannot be opened by the IRB

21. Possible causes of delays (cont’d) • Investigator causes of delays: • Attaching files in a format that cannot be opened by the IRB • Including protocol version dates in protocol titles, but not updating them when the version changes • Making personnel changes in one document but not another • Requesting a waiver of consent or documentation of consent, but not providing the justification • Selecting names of attached files that are not related to the file, thus requiring IRB staff/members to open each document to find a specific file

22. Possible causes of delays (cont’d) • 2) IRB causes of delays: • Lack of clarity of Rascal functions with staff • Lack of clarity of Rascal functions with IRB members • Inflexibility of an electronic IT system

23. Solutions/Plans to Improve IRB Quality and Performance • Provide more educational training targeted to issues related to IRB delays • - Start regular workshops on RASCAL training? • Improve IRB’s website so that it becomes a valuable resource • Improve management of IRB office; use of tracking systems, increase accountability and performance • Improve IRB committees by adding to the already high level of expertise with representation of more disciplines

24. Tips to avoid IRB delays and returns • Review the “Tips to Facilitate Efficient Review” documents on the IRB website • Complete all fields in RASCAL, entering “NA” if appropriate • Read the information on the Help buttons in the RASCAL screens • Use cover letters attached to the submission to communicate to the IRB • Review the list of attachments before each submission and archive superceded or obsolete documents • Verify the protocol status after you “submit” and event • Submit renewals 60 days prior to the expiration date

25. Policy or Procedural Changes in IRB • April 1, 2004 – Discontinued continuing review of exempt research • April 13, 2004 – Released new AE Reporting policy • September 2004 – Implementation of accountability measures in IRB • December 16, 2004 – RASCAL change: Allowing renewals to be resubmitted for expired protocols

26. IRB Goals for 2005 • Apply for Accreditation and receive full accreditation status • Improve the efficiency of the IRB so that average turnaround time is less than 2 months • Improve the quality of IRB review • Improve the quality of Columbia’s human subjects protection program