1. CUMC IRB Investigator Meeting Status of the IRB January 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 MonthTotal January284 February336 March415 April522 May483 June562 July577 August630 September588 October618 November640 December639

5. 2004 Staffing levels of the IRB adjusted for leave Staff January27.74 February27.8 March26.63 April26.2 May26.4 June21.09 July22.5 August20.77 September19.26 October19.38 November19.4 December18.61

6. 2004 Total approvals by CU/CUMC IRBs

8. Individual IRB Performance – Turnaround Time Expedited Review IRB“K” (coded) Prot. #ReviewSub dateApp'l dateTotalIRBPI# Returns A1455Exp312234010412570.03 A4136Exp30123301285501 A3010Exp4011440201181442 A3107Exp4031140402216151 A2379Exp310154040617461681 A4537Exp4022740406395341 A7131Exp40514407075314391 A6154Exp40514407075333201 A6819Exp40602407103818203 A6860Exp40702410139443513 A9618Exp4090741005287211 A9676Exp410014101211921 Total546165381 Average45.513.7531.751.335833

9. Individual IRB Performance – Turnaround Time Full Board Review IRB“K” (coded) Prot. #ReviewSub dateApp'l dateTotalIRBPI# Returns A1186FB31124401074330132 A1902FB31031401187930492 A3919FB3123040130312921 A2649FB312054040612346773 A0174FB3111940406139301092 A4506FB40226404145025 1 A5771FB40408407129563323 A6615FB40421407128254292 A7958FB406214070716 00 A5304FB4031141005208401683 A6281FB404124100517684924 A7666FB407164102710340632 Total1145487659 Average95.4166740.5833354.916672.083333

10. Individual IRB Performance – Turnaround Time Expedited Review IRB“L” (coded) Prot. #ReviewSub dateApp'l dateTotalIRBPI# Returns A3707Exp31224401029900 A3389Exp31204401043120111 A3784Exp3121940107191812 A2857Exp40302404083723142 A6674Exp40419404223300 A5588Exp4040540423184141 A5908Exp40603407012815132 A7967Exp406154070116 00 A6014Exp4062240708161151 A9041Exp40806410045943162 B0070Exp409304101212 00 B0050Exp409294101213 00 Total26118774 Average21.7515.583336.1666670.916667

11. Individual IRB Performance – Turnaround Time Full Board Review IRB“L” (coded) Prot. #ReviewSub dateApp'l dateTotalIRBPI# Returns A1307FB307244010516591741 A2643FB3013031217484082 A2596FB31021401027345285 A2368FB3102140403165108575 A3921FB40227404053825132 A4591FB40210404055522232 A2926FB403244070310166351 A4792FB40414407038043373 A5398FB40406407038876121 A8030FB40629410019583122 A6806FB406164101111785323 A8826FB40729410117464103 Total1099748341 Average91.5833362.3333328.416672.5

12. Individual IRB Performance – Turnaround Time Expedited Review IRB“M” (coded) Prot. #ReviewSub dateApp'l dateTotalIRBPI# Returns A1699Exp3081940114148431052 A1520Exp31021401158639474 A0200Exp3040740122290412493 A2578Exp4021440411575431 A4323Exp40202404116945242 A3752Exp312174041111657593 A6194Exp4062540716211562 A3070Exp3121240727228691595 A5920Exp40506407278238444 A8480Exp40715410017939401 A8712Exp40720410017459152 A7631Exp406114101012151702 Total1371550821 Average114.2545.8333368.416672.583333

13. Individual IRB Performance – Turnaround Time Full Board Review IRB“M” (coded) Prot. #ReviewSub dateApp'l dateTotalIRBPI# Returns A2696FB3103140105666421 A2363FB31010401129463314 A4143FB40122404057448262 A1823FB311254040613244882 A1562FB311174040914396474 A1500FB30728407053421122303 A0360FB30611407053901492417 A1789FB4010840705178651133 A8837FB40816410014635112 B0177FB40930410066601 A2466FB4082441010473891 Total1518720798 Average13865.4545572.545452.727273

14. Individual IRB Performance – Turnaround Time Expedited Review IRB“N” (coded) Prot. #ReviewSub dateApp'l dateTotalIRBPI# Returns A3750Exp31223401019900 A3325Exp3120740105292811 A1414Exp310014011511631131 A5319Exp4032440412191542 A6074Exp403254042026 00 A5528Exp4031540420363331 A7738Exp4061540709249151 A8001Exp40614407143017132 A7764Exp40615407213623133 A9899Exp409204100616 00 A8466Exp4092141011201461 A9103Exp409234101320 00 Total381213168 Average31.7517.75141

15. Individual IRB Performance – Turnaround Time Full Board Review IRB“N” (coded) Prot. #ReviewSub dateApp'l dateTotalIRBPI# Returns A3142FB3112340115534941 A1812FB31210401284930194 A3077FB401084012113672 A4484FB403114040120 00 A1985FB3092240405196501467 A3073FB40212404276955142 A2886FB40512406304938111 A6716FB4051240711605732 A7673FB4060240714484261 A8347FB40806410056040201 A8885FB40819410064838102 A9370FB4091641011252051 Total690445245 Average57.537.0833320.416672

16. Individual IRB Performance – Turnaround Time Expedited Review 2004 Days IRB # From Days Days Studies Subm. To w/ w/ # Approval IRB PI Returns IRB K Total 12546 165 381 16 IRB L Total 12261 187 74 11 IRB M Total 121371 550 821 29 IRB N Total 12381 213 168 12 Total 482,559 1,115 1,444 68 Average53 days23 days 30 days 1.42 IRBs are coded to maintain confidentiality Total of 48 studies

17. Individual IRB Performance – Turnaround Time Full Boards Review 2004 Days IRB # From Days Days Studies Subm. To w/ w/ # Approval IRB PI Returns IRBs are coded to maintain confidentiality Total of 48 studies IRB K Total12 1,145 487 659 25 IRB L Total12 1,099 748 341 30 IRB M Total 12 1,518 720 798 30 IRB N Total12 690 445 245 24 Total48 4,452 2,400 2,043 109 Average 93 days 50 days 43 days 2.27

18. Factors affecting data on IRB delays 1)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 1)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) 1)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