1 strategies and suggestions for managing the irb process in va queri implementation studies retides...

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Strategies and Suggestions for Strategies and Suggestions for Managing the IRB process in VA Managing the IRB process in VA QUERI implementation studiesQUERI implementation studies

• ReTIDES Project IRB Team:ReTIDES Project IRB Team:– Edmund Chaney, Debbie Mittman, Carol Edmund Chaney, Debbie Mittman, Carol

Simons, Barbara Simon, Laura Rabuck, Simons, Barbara Simon, Laura Rabuck, Laura Bonner, Mona Ritchie and Lisa Laura Bonner, Mona Ritchie and Lisa RubensteinRubenstein

• VA R&D COACH Staff:VA R&D COACH Staff:– Marisue CodyMarisue Cody

• VA HSR&D CyberseminarVA HSR&D Cyberseminar– February 2 & 9, 2009 February 2 & 9, 2009

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AcknowledgementAcknowledgement

• Studies on which this presentation is based Studies on which this presentation is based were quality improvement and action were quality improvement and action research partnerships with VISN, VAMC, research partnerships with VISN, VAMC, Practice and CO clinical and administrative Practice and CO clinical and administrative staff, without whose active leadership and staff, without whose active leadership and participation nothing would have been participation nothing would have been accomplished.accomplished.

• Mental Health QUERI, and Sepulveda, Mental Health QUERI, and Sepulveda, Seattle and Little Rock HSR&D COEs likewise Seattle and Little Rock HSR&D COEs likewise provided invaluable support.provided invaluable support.

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IntroductionIntroduction

• Ethical Issues and protection of Human Ethical Issues and protection of Human Subjects are integral to implementation Subjects are integral to implementation researchresearch

• Everyone benefits if management of IRB Everyone benefits if management of IRB issues is collaborative rather than issues is collaborative rather than adversarial adversarial

• Building relationships with all involved Building relationships with all involved parties is central to effective management parties is central to effective management

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A Narrative Explication of Risk A Narrative Explication of Risk Management Challenges in Management Challenges in Implementation ResearchImplementation Research

• Background and Overview – Background and Overview – Ed ChaneyEd Chaney

• Protocol Development – Protocol Development – Mona RitchieMona Ritchie

• Site Identification and Assessment – Site Identification and Assessment – Carol Simons Carol Simons

• Establishing Relationships with Site PIs and IRBs – Establishing Relationships with Site PIs and IRBs – Laura Rabuck Laura Rabuck

• Managing Multiple Sites and Systems – Managing Multiple Sites and Systems – Barbara Barbara Simon & Debbie MittmanSimon & Debbie Mittman

• Managing High Risk Issues – Managing High Risk Issues – Laura BonnerLaura Bonner

• VA Central IRB –VA Central IRB – Marisue Cody Marisue Cody

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What are the primary studies on which What are the primary studies on which this narrative is based?this narrative is based?

• The TIDES family of studies: Translating The TIDES family of studies: Translating Initiatives in Depression into Effective Initiatives in Depression into Effective SolutionsSolutions

• 2000: TIDES - Can VA implement 2000: TIDES - Can VA implement collaborative care for depression in collaborative care for depression in primary care as part of routine care?primary care as part of routine care?

• 2004: Regional TIDES - Use TIDES to study 2004: Regional TIDES - Use TIDES to study implementation issues necessary for implementation issues necessary for national VA rolloutnational VA rollout

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TIDES is An Evidence-Based Quality TIDES is An Evidence-Based Quality Improvement ProjectImprovement Project

• Design based on successive Plan-Do-Design based on successive Plan-Do-Study-Act Cycles (PDCA) Study-Act Cycles (PDCA) – Starting point for PDSA’s is evidence from the Starting point for PDSA’s is evidence from the

literatureliterature– VISN leaders decided on general program VISN leaders decided on general program

features through an expert panel processfeatures through an expert panel process– Regional and local team-based quality Regional and local team-based quality

improvement process was flexible and variableimprovement process was flexible and variable

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VAMC(3,836 PC Patients)



CBOC(4,906 PC Patients)



CBOC(7,604 P PC Patients)




Intervention Sites

Control Sites

TIDES Primary Care Clinic Sites

2 new VAMC’s (90,000 PC Patients)

9 New VAMC’s (90,000 PC Patients)



ReTIDES Spread

VISN MAP of TIDES and ReTIDES

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QUERI Water PIPELINEQUERI Water PIPELINE

PIC, MHAP, MOOD,IMPACT, RESPECT, TEAM

Health Service Research

Implementation Science

Implementation Policy

TIDES

WAVES

RETIDES

COVES

HITIDES

RIPPLE

DepressionCare

Guidelines

DepressionCollaborativeCare Model

Revise Guidelines

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Research Methods IResearch Methods I

• TIDES – Quality ImprovementTIDES – Quality Improvement– Expert Panel questionnaireExpert Panel questionnaire– Depression Care Manager QI logsDepression Care Manager QI logs

• WAVES – RCT, Site randomizationWAVES – RCT, Site randomization– Patient structured telephone questionnairesPatient structured telephone questionnaires– Patient level analysis of administrative data Patient level analysis of administrative data

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Research Methods IIResearch Methods II

• COVES – Mixed Method EvaluationCOVES – Mixed Method Evaluation– Site level stakeholder interviewsSite level stakeholder interviews– Cost analysisCost analysis

• ReTIDES – Multi-method Implementation ReTIDES – Multi-method Implementation – 18 month follow-up of WAVES outcomes18 month follow-up of WAVES outcomes– Provider Internet surveyProvider Internet survey– Site level analysis of administrative dataSite level analysis of administrative data– Qualitative system level stakeholder interviewsQualitative system level stakeholder interviews

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Method ComplexityMethod Complexity

• Multi-level data collection Multi-level data collection – Organizational leadersOrganizational leaders– Clinic managersClinic managers– Providers Providers – Patients Patients – Administrative record abstraction. Administrative record abstraction.

• Multi-mode data collection Multi-mode data collection – Qualitative interviewsQualitative interviews– Quantitative surveysQuantitative surveys

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Protocol DevelopmentProtocol Development

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Protocol DevelopmentProtocol Development

BackgroundBackground

• Usual challenges of multiple study sitesUsual challenges of multiple study sites

• Unique Challenges (& Resources)Unique Challenges (& Resources)– Multiple administrative sitesMultiple administrative sites– Multiple related studiesMultiple related studies

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Protocol DevelopmentProtocol DevelopmentIndividual StudiesIndividual Studies

• Comparison of application forms & Comparison of application forms & processes across sitesprocesses across sites

• Different protocol submission processesDifferent protocol submission processes– Conventional approach (entire protocol)Conventional approach (entire protocol)

• Advantage: single submissionAdvantage: single submission• Disadvantage: lack of flexibilityDisadvantage: lack of flexibility

– Component approachComponent approach• Advantage: flexibility in accommodating site Advantage: flexibility in accommodating site

differences and detailed description of componentsdifferences and detailed description of components• Disadvantage: multiple submissionsDisadvantage: multiple submissions

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Protocol DevelopmentProtocol DevelopmentMultiple Administrative SitesMultiple Administrative Sites

• Planning & strategizingPlanning & strategizing

• Coordinating protocol developmentCoordinating protocol development

• Tailoring protocols to administrative Tailoring protocols to administrative sitessites

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Protocol DevelopmentProtocol DevelopmentInformed Consent ProcessesInformed Consent Processes

• VA EmployeesVA Employees– Waiver of documentationWaiver of documentation– ManagersManagers

• engage from the top downengage from the top down

• inform as you goinform as you go

– StaffStaff• Schedule with permissionSchedule with permission

• Inform and consentInform and consent

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Protocol DevelopmentProtocol DevelopmentInformed Consent Processes (cont’d)Informed Consent Processes (cont’d)

• Patient recruitment across studiesPatient recruitment across studies– Study #1: Study #1:

• get permission to call backget permission to call back

• Using a brief script for study #2, call and schedule Using a brief script for study #2, call and schedule randomly selected subjectsrandomly selected subjects

– Study #2:Study #2:• Study information letter confirming appointmentStudy information letter confirming appointment

• Formal consent process at time of contactFormal consent process at time of contact

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Protocol Development:Protocol Development:Building on Previous StudiesBuilding on Previous Studies

Following the FundingFollowing the Funding

vs.vs.

Following the ResearchFollowing the Research

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Site Identification and AssessmentSite Identification and Assessment

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Site factors which impact the IRB Site factors which impact the IRB working relationshipworking relationship• Site IRBSite IRB

– Familiarity with Implementation Research (IR) Familiarity with Implementation Research (IR) – Site specific policies, procedures, forms, Site specific policies, procedures, forms,

customs, and workloadcustoms, and workload

• Site PI Site PI – Experience Experience – Professional focus (research, clinical, mixed)Professional focus (research, clinical, mixed)– Comfort level with research and IRB tasksComfort level with research and IRB tasks– Local resources (time, staffing, etc)Local resources (time, staffing, etc)

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CommunicationCommunication

• How will ongoing study human subjects How will ongoing study human subjects issues be decided?issues be decided?

• How will this be communicated to How will this be communicated to everyone who needs to know?everyone who needs to know?

• Identifying key players and having the Identifying key players and having the ability to contact them as needed.ability to contact them as needed.

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CollaborationCollaboration

• Discuss in advance who is doing what Discuss in advance who is doing what – This involvesThis 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 Determine how (non-fiscal) research support should be centralized, local or support should be centralized, local or mixed, etc. mixed, etc.

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InformationInformation

• Good Intel – the more you know about Good Intel – the more you know about what to expect from working with an IRB what to expect from working with an IRB the better you can preparethe better you can prepare

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InformantsInformants

– Current or potential site PIsCurrent or potential site PIs– Local IRB staffLocal IRB staff– Colleagues at siteColleagues at site

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Electronic data sourcesElectronic data sources• ART Reporter (aka ART Criteria Searches)ART Reporter (aka ART Criteria Searches)

– It is a VA Intranet site It is a VA Intranet site – Search for studies by siteSearch for studies by site– May tell you how familiar the site IRB is with IRMay tell you how familiar the site IRB is with IR– ((http://art.puget-sound.med.va.gov/reporter.cfmhttp://art.puget-sound.med.va.gov/reporter.cfm))

• IRB WebsitesIRB Websites – Forms & manualsForms & manuals– IRB expectations IRB expectations – This information may give you some sense of how This information may give you some sense of how

much time and effort an application to their site may much time and effort an application to their site may requirerequire

http://art.puget-sound.med.va.gov/reporter.cfm

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Establishing Relationships with Establishing Relationships with Site Principal InvestigatorsSite Principal Investigators

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Multiple Local Site PIs Multiple Local Site PIs

• Herding cats!Herding cats!

• Challenges in 4 Challenges in 4 main areasmain areas

• Process aids Process aids developed in developed in response to response to challenges challenges

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Multiple Local Site PI Multiple Local Site PI ChallengesChallenges

• RecruitmentRecruitment– Finding interested & capable Finding interested & capable

researchers at local sitesresearchers at local sites

• Research experience & Research experience & availabilityavailability– With their local IRBWith their local IRB– Within existing commitmentsWithin existing commitments

• Ethics certificationEthics certification – Variability in annual deadlinesVariability in annual deadlines

• Level of involvementLevel of involvement– Sometimes connected to availabilitySometimes connected to availability

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Multiple Local Site PIMultiple Local Site PI Process Aids Process Aids

• Project Implementation Charter & Site Project Implementation Charter & Site Memorandum of AgreementMemorandum of Agreement

• Site PI Orientation ChecklistSite PI Orientation Checklist

• IRB Relational DatabaseIRB Relational Database

• Meetings/workgroups/manuscriptsMeetings/workgroups/manuscripts

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Managing Multiple Sites & SystemsManaging Multiple Sites & Systems

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• Maintain accountability across Maintain accountability across systems/sitessystems/sites

• Build and maintain trust relationships with Build and maintain trust relationships with multiple IRBs multiple IRBs

• Support on-going site PI communication Support on-going site PI communication and facilitate complianceand facilitate compliance

• Foster adherence to site-specific protocols Foster adherence to site-specific protocols and approvalsand approvals

• Minimize participant and institutional riskMinimize participant and institutional risk

Managing Multiple Sites & Managing Multiple Sites & Systems:Systems: Multidimensional goals Multidimensional goals

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Managing Multiple Sites & SystemsManaging Multiple Sites & SystemsGoal: Goal: Maintain accountability across systems & sitesMaintain accountability across systems & sites– Centralize IRB documents & management at a single Centralize IRB documents & management at a single

site site

Tools:Tools:• IRB relational databaseIRB relational database

– Data management software for tracking and monitoring compliance Data management software for tracking and monitoring compliance across sitesacross sites

• IRB working groupIRB working group– Served as forum for assessing ethical approaches to protocol Served as forum for assessing ethical approaches to protocol

submissions and riskssubmissions and risks– Used reports derived from database to assess and monitor Used reports derived from database to assess and monitor

compliance compliance

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Screen Shot of Relational IRB Screen Shot of Relational IRB Tracking Database (AccessTracking Database (Access) )

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Goal:Goal:Build and maintain trust relationships with Build and maintain trust relationships with multiple IRBsmultiple IRBs• Gather information to aid compliance, rapport, Gather information to aid compliance, rapport,

efficient submission and to improve likelihood of efficient submission and to improve likelihood of approvalapproval

Tools:Tools:• IRB Contact Questionnaire for individual IRBsIRB 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 Use IRB working group as forum for assessing

strategies strategies

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Goal:Goal:Support on-going site PI communication Support on-going site PI communication and facilitate complianceand facilitate compliance

Tool: Relational database Tool: Relational database •stores contact information, certification statusstores contact information, certification status

•facilitates feedback on submission deadlines, facilitates feedback on submission deadlines, IRB/R&D meeting datesIRB/R&D meeting dates

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Goal:Goal:Adherence to site-specific protocols and Adherence to site-specific protocols and approval type approval type – Identify protocol and approval differences across Identify protocol and approval differences across

sitessites

Tool: Relational databaseTool: Relational database• records differences and generates reportsrecords differences and generates reports

Tool: IRB working group Tool: IRB working group • uses reports to assess, track and monitor adherence uses reports to assess, track and monitor adherence

across sites across sites

Managing Multiple Sites & Systems Managing Multiple Sites & Systems

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Goal:Goal:Minimize risk to participants & institutionsMinimize risk to participants & institutions– Gathered information to identify AE/SAE Gathered information to identify AE/SAE

differences in definitions and reporting differences in definitions and reporting requirements across IRBs requirements across IRBs

– Created table to enable systematic assessment Created table to enable systematic assessment of differences of differences

Tool: IRB relational database Tool: IRB relational database • Tracked compliance with reporting requirements Tracked compliance with reporting requirements

Managing Multiple Sites & Managing Multiple Sites & SystemsSystems

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• How were overall management goals met?How were overall management goals met?– Centralized records at coordinating siteCentralized records at coordinating site– Created a dedicated staff position for IRB Created a dedicated staff position for IRB

compliance activitiescompliance activities– Tasked IRB working group with responsibility Tasked IRB working group with responsibility

for managing IRB process across sitesfor managing IRB process across sites– Developed a relational database to track Developed a relational database to track

submissions, approvals, other functions submissions, approvals, other functions

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Managing High Risk IssuesManaging High Risk Issues

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High-risk patients in the context of High-risk patients in the context of implementation studiesimplementation studies

• High-risk veterans require special planning High-risk veterans require special planning throughout protocol developmentthroughout protocol development

• TIDES studied veterans TIDES studied veterans – With depressionWith depression– Not receiving mental health care at time of Not receiving mental health care at time of

study enrollmentstudy enrollment– Therefore, at high risk of suicideTherefore, at high risk of suicide

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Multi-step approach to assessment Multi-step approach to assessment and safetyand safety planningplanning

• Trained non-clinician research staff detect riskTrained non-clinician research staff detect risk

• Clinical staff perform in-depth assessment as Clinical staff perform in-depth assessment as needed (Campbell et al., 2008; Bonner et al., needed (Campbell et al., 2008; Bonner et al., 2008)2008)

• Local resources are utilized as requiredLocal resources are utilized as required

• Requires intensive communication among site Requires intensive communication among site and research personnel at all levelsand research personnel at all levels

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Dialogue with IRB regarding Dialogue with IRB regarding impact on high-risk populationsimpact on high-risk populations

• Highest risk comes from participants’ pre-Highest risk comes from participants’ pre-existing issues, not from the interventionexisting issues, not from the intervention

• Consideration of ethical issues of not Consideration of ethical issues of not allowing high-risk groups to participate in allowing high-risk groups to participate in researchresearch

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Creation of a multi-site, multi-level Creation of a multi-site, multi-level risk management teamrisk management team

• Sites have varied resourcesSites have varied resources– PI time/other commitmentsPI time/other commitments– Extant policiesExtant policies– Mental health coverage/clinical backupMental health coverage/clinical backup– Local community EMSLocal community EMS

• Research team creates comprehensive policyResearch team creates comprehensive policy• Works with sites to customize for local conditionsWorks with sites to customize for local conditions• May benefit sites by initiating a detailed May benefit sites by initiating a detailed

examination of pre-existing policiesexamination of pre-existing policies

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Risk managementRisk management

IRBsAt-risk patients

Site Resources

Research team

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Update on VA Central IRBUpdate on VA Central IRB

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Information ResourcesInformation Resources

• COACHCOACH– http://www.research.va.gov/programs/PRIDEhttp://www.research.va.gov/programs/PRIDE

• Implementation Science QUERI Human Implementation Science QUERI Human Subjects Issues article and appendicesSubjects Issues article and appendices– http://www.implementationscience.com/http://www.implementationscience.com/

content/3/1/10content/3/1/10

• Organizations such as Public Responsibility Organizations such as Public Responsibility in Medicine and Researchin Medicine and Research– http://www.primr.org/http://www.primr.org/

1 strategies and suggestions for managing the irb process in va queri implementation studies retides...

Documents

management of irb issues

administrative staff

irb process

primary care

collaborative care

regional tides use tides

tides family of studies

introductionethical