1. 1 Strategies and Suggestions for Managing the IRB process in VA QUERI implementation studies ReTIDES Project IRB Team: ReTIDES Project IRB Team: –Edmund Chaney, Debbie Mittman, Carol Simons, Barbara Simon, Laura Rabuck, Laura Bonner, Mona Ritchie and Lisa Rubenstein VA R&D COACH Staff: VA R&D COACH Staff: –Marisue Cody VA HSR&D Cyberseminar VA HSR&D Cyberseminar –February 2 & 9, 2009

2. 2 Acknowledgement Studies on which this presentation is based were quality improvement and action research partnerships with VISN, VAMC, Practice and CO clinical and administrative staff, without whose active leadership and participation nothing would have been accomplished. Studies on which this presentation is based were quality improvement and action research partnerships with VISN, VAMC, Practice and CO clinical and administrative staff, without whose active leadership and participation nothing would have been accomplished. Mental Health QUERI, and Sepulveda, Seattle and Little Rock HSR&D COEs likewise provided invaluable support. Mental Health QUERI, and Sepulveda, Seattle and Little Rock HSR&D COEs likewise provided invaluable support.

3. 3 Introduction Ethical Issues and protection of Human Subjects are integral to implementation research Ethical Issues and protection of Human Subjects are integral to implementation research Everyone benefits if management of IRB issues is collaborative rather than adversarial Everyone benefits if management of IRB issues is collaborative rather than adversarial Building relationships with all involved parties is central to effective management Building relationships with all involved parties is central to effective management

4. 4 A Narrative Explication of Risk Management Challenges in Implementation Research Background and Overview – Ed Chaney Background and Overview – Ed Chaney Protocol Development – Mona Ritchie Protocol Development – Mona Ritchie Site Identification and Assessment – Carol Simons Site Identification and Assessment – Carol Simons Establishing Relationships with Site PIs and IRBs – Laura Rabuck Establishing Relationships with Site PIs and IRBs – Laura Rabuck Managing Multiple Sites and Systems – Barbara Simon & Debbie Mittman Managing Multiple Sites and Systems – Barbara Simon & Debbie Mittman Managing High Risk Issues – Laura Bonner Managing High Risk Issues – Laura Bonner VA Central IRB – Marisue Cody VA Central IRB – Marisue Cody

5. 5 What are the primary studies on which this narrative is based? The TIDES family of studies: Translating Initiatives in Depression into Effective Solutions The TIDES family of studies: Translating Initiatives in Depression into Effective Solutions 2000: TIDES - Can VA implement collaborative care for depression in primary care as part of routine care? 2000: TIDES - Can VA implement collaborative care for depression in primary care as part of routine care? 2004: Regional TIDES - Use TIDES to study implementation issues necessary for national VA rollout 2004: Regional TIDES - Use TIDES to study implementation issues necessary for national VA rollout

6. 6 TIDES is An Evidence-Based Quality Improvement Project Design based on successive Plan-Do-Study-Act Cycles (PDCA) Design based on successive Plan-Do-Study-Act Cycles (PDCA) –Starting point for PDSA’s is evidence from the literature –VISN leaders decided on general program features through an expert panel process –Regional and local team-based quality improvement process was flexible and variable

7. 7 2 new VAMC’s (90,000 PC Patients) 9 New VAMC’s (90,000 PC Patients) 2 New VAMC’s (40,000 PC Patients) 2 New VAMC’s (40,000 PC Patients) ReTIDES Spread VISN MAP of TIDES and ReTIDES

8. 8 QUERI Water PIPELINE PIC, MHAP, MOOD,IMPACT, RESPECT, TEAM Health Service Research Implementation Science Implementation Policy TIDESTIDES WAVESWAVES RETIDESRETIDES COVESCOVES HITIDESHITIDES RIPPLERIPPLE Depression Care Guidelines Depression Collaborative Care Model Revise Guidelines

9. 9 Research Methods I TIDES – Quality Improvement TIDES – Quality Improvement –Expert Panel questionnaire –Depression Care Manager QI logs WAVES – RCT, Site randomization WAVES – RCT, Site randomization –Patient structured telephone questionnaires –Patient level analysis of administrative data

10. 10 Research Methods II COVES – Mixed Method Evaluation COVES – Mixed Method Evaluation –Site level stakeholder interviews –Cost analysis ReTIDES – Multi-method Implementation ReTIDES – Multi-method Implementation –18 month follow-up of WAVES outcomes –Provider Internet survey –Site level analysis of administrative data –Qualitative system level stakeholder interviews

11. 11 Method Complexity Method Complexity Multi-level data collection Multi-level data collection –Organizational leaders –Clinic managers –Providers –Patients –Administrative record abstraction. Multi-mode data collection Multi-mode data collection –Qualitative interviews –Quantitative surveys

12. 12 Protocol Development

13. 13 Protocol Development Background Usual challenges of multiple study sites Usual challenges of multiple study sites Unique Challenges (& Resources) Unique Challenges (& Resources) –Multiple administrative sites –Multiple related studies

14. 14 Protocol Development Individual Studies Comparison of application forms & processes across sites Comparison of application forms & processes across sites Different protocol submission processes Different protocol submission processes –Conventional approach (entire protocol) Advantage: single submission Advantage: single submission Disadvantage: lack of flexibility Disadvantage: lack of flexibility –Component approach Advantage: flexibility in accommodating site differences and detailed description of components Advantage: flexibility in accommodating site differences and detailed description of components Disadvantage: multiple submissions Disadvantage: multiple submissions

15. 15 Protocol Development Multiple Administrative Sites Planning & strategizing Planning & strategizing Coordinating protocol development Coordinating protocol development Tailoring protocols to administrative sites Tailoring protocols to administrative sites

16. 16 Protocol Development Informed Consent Processes VA Employees VA Employees –Waiver of documentation –Managers engage from the top down engage from the top down inform as you go inform as you go –Staff Schedule with permission Schedule with permission Inform and consent Inform and consent

17. 17 Protocol Development Informed Consent Processes (cont’d) Patient recruitment across studies Patient recruitment across studies –Study #1: get permission to call back get permission to call back Using a brief script for study #2, call and schedule randomly selected subjects Using a brief script for study #2, call and schedule randomly selected subjects –Study #2: Study information letter confirming appointment Study information letter confirming appointment Formal consent process at time of contact Formal consent process at time of contact

18. 18 Protocol Development: Building on Previous Studies Following the Funding vs. Following the Research

19. 19 Site Identification and Assessment

20. 20 Site factors which impact the IRB working relationship Site IRB Site IRB –Familiarity with Implementation Research (IR) –Site specific policies, procedures, forms, customs, and workload Site PI Site PI –Experience –Professional focus (research, clinical, mixed) –Comfort level with research and IRB tasks –Local resources (time, staffing, etc)

21. 21 Communication How will ongoing study human subjects issues be decided? How will ongoing study human subjects issues be decided? How will this be communicated to everyone who needs to know? How will this be communicated to everyone who needs to know? Identifying key players and having the ability to contact them as needed. Identifying key players and having the ability to contact them as needed.

22. 22 Collaboration Discuss in advance who is doing what Discuss in advance who is doing what –This involves Clarifying roles Clarifying roles Deciding how tasks will be shared or delegated. Deciding how tasks will be shared or delegated. Determine how (non-fiscal) research support should be centralized, local or mixed, etc. Determine how (non-fiscal) research support should be centralized, local or mixed, etc.

23. 23 Information Good Intel – the more you know about what to expect from working with an IRB the better you can prepare Good Intel – the more you know about what to expect from working with an IRB the better you can prepare

24. 24 Informants –Current or potential site PIs –Local IRB staff –Colleagues at site

25. 25 Electronic data sources ART Reporter (aka ART Criteria Searches) ART Reporter (aka ART Criteria Searches) –It is a VA Intranet site –Search for studies by site –May tell you how familiar the site IRB is with IR – (http://art.puget-sound.med.va.gov/reporter.cfm) http://art.puget-sound.med.va.gov/reporter.cfm IRB Websites IRB Websites –Forms & manuals –IRB expectations –This information may give you some sense of how much time and effort an application to their site may require

26. 26 Establishing Relationships with Site Principal Investigators

27. 27 Multiple Local Site PIs Herding cats! Herding cats! Challenges in 4 main areas Challenges in 4 main areas Process aids developed in response to challenges Process aids developed in response to challenges

28. 28 Multiple Local Site PI Challenges Recruitment Recruitment –Finding interested & capable researchers at local sites Research experience & availability Research experience & availability –With their local IRB –Within existing commitments Ethics certification Ethics certification –Variability in annual deadlines Level of involvement Level of involvement –Sometimes connected to availability

29. 29 Multiple Local Site PI Process Aids Project Implementation Charter & Site Memorandum of Agreement Project Implementation Charter & Site Memorandum of Agreement Site PI Orientation Checklist Site PI Orientation Checklist IRB Relational Database IRB Relational Database Meetings/workgroups/manuscripts Meetings/workgroups/manuscripts

30. 30 Managing Multiple Sites & Systems

31. 31 Maintain accountability across systems/sites Maintain accountability across systems/sites Build and maintain trust relationships with multiple IRBs Build and maintain trust relationships with multiple IRBs Support on-going site PI communication and facilitate compliance Support on-going site PI communication and facilitate compliance Foster adherence to site-specific protocols and approvals Foster adherence to site-specific protocols and approvals Minimize participant and institutional risk Minimize participant and institutional risk Managing Multiple Sites & Systems: Multidimensional goals

32. 32 Managing Multiple Sites & Systems Goal: Maintain accountability across systems & sites –Centralize IRB documents & management at a single site Tools: IRB relational database IRB relational database –Data management software for tracking and monitoring compliance across sites IRB working group IRB working group –Served as forum for assessing ethical approaches to protocol submissions and risks –Used reports derived from database to assess and monitor compliance

33. 33 Screen Shot of Relational IRB Tracking Database (Access )

34. 34 Managing Multiple Sites & Systems Goal: Build and maintain trust relationships with multiple IRBs Gather information to aid compliance, rapport, efficient submission and to improve likelihood of approvalGather information to aid compliance, rapport, efficient submission and to improve likelihood of approvalTools: IRB Contact Questionnaire for individual IRBs IRB Contact Questionnaire for individual IRBs Enter information in relational database (multiple uses) Enter information in relational database (multiple uses) Use IRB working group as forum for assessing strategies Use IRB working group as forum for assessing strategies

35. 35 Managing Multiple Sites & Systems Goal: Support on-going site PI communication and facilitate compliance Tool: Relational database stores contact information, certification status stores contact information, certification status facilitates feedback on submission deadlines, IRB/R&D meeting dates facilitates feedback on submission deadlines, IRB/R&D meeting dates

36. 36 Goal: Adherence to site-specific protocols and approval type –Identify protocol and approval differences across sites Tool: Relational database records differences and generates reports records differences and generates reports Tool: IRB working group uses reports to assess, track and monitor adherence across sites uses reports to assess, track and monitor adherence across sites Managing Multiple Sites & Systems

37. 37 Goal: Minimize risk to participants & institutions –Gathered information to identify AE/SAE differences in definitions and reporting requirements across IRBs –Created table to enable systematic assessment of differences Tool: IRB relational database Tracked compliance with reporting requirements Tracked compliance with reporting requirements Managing Multiple Sites & Systems

38. 38 Managing Multiple Sites & Systems How were overall management goals met? How were overall management goals met? –Centralized records at coordinating site –Created a dedicated staff position for IRB compliance activities –Tasked IRB working group with responsibility for managing IRB process across sites –Developed a relational database to track submissions, approvals, other functions

39. 39 Managing High Risk Issues

40. 40 High-risk patients in the context of implementation studies High-risk veterans require special planning throughout protocol development High-risk veterans require special planning throughout protocol development TIDES studied veterans TIDES studied veterans –With depression –Not receiving mental health care at time of study enrollment –Therefore, at high risk of suicide

41. 41 Multi-step approach to assessment and safety planning Trained non-clinician research staff detect risk Trained non-clinician research staff detect risk Clinical staff perform in-depth assessment as needed (Campbell et al., 2008; Bonner et al., 2008) Clinical staff perform in-depth assessment as needed (Campbell et al., 2008; Bonner et al., 2008) Local resources are utilized as required Local resources are utilized as required Requires intensive communication among site and research personnel at all levels Requires intensive communication among site and research personnel at all levels

42. 42 Dialogue with IRB regarding impact on high-risk populations Highest risk comes from participants’ pre- existing issues, not from the intervention Highest risk comes from participants’ pre- existing issues, not from the intervention Consideration of ethical issues of not allowing high-risk groups to participate in research Consideration of ethical issues of not allowing high-risk groups to participate in research

43. 43 Creation of a multi-site, multi-level risk management team Sites have varied resources Sites have varied resources –PI time/other commitments –Extant policies –Mental health coverage/clinical backup –Local community EMS Research team creates comprehensive policy Research team creates comprehensive policy Works with sites to customize for local conditions Works with sites to customize for local conditions May benefit sites by initiating a detailed examination of pre-existing policies May benefit sites by initiating a detailed examination of pre-existing policies

44. 44 Risk management Research team Site Resources At-risk patients IRBs

45. 45 Update on VA Central IRB

46. 46 Information Resources COACH COACH –http://www.research.va.gov/programs/PRIDE Implementation Science QUERI Human Subjects Issues article and appendices Implementation Science QUERI Human Subjects Issues article and appendices –http://www.implementationscience.com/content/3/1/ 10 Organizations such as Public Responsibility in Medicine and Research Organizations such as Public Responsibility in Medicine and Research –http://www.primr.org/