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

Marisue Cody
        - VA HSR&D Cyberseminar

February 2 & 9, 2009 

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

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

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

What are the primary studies on which this narrative is based?
        - 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?
        - 2004: Regional TIDES - Use TIDES to study implementation issues necessary for           national VA rollout

TIDES is An Evidence-Based Quality Improvement Project
        - 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

VISN MAP of TIDES and ReTIDES

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

This is where we are now.  Pale yellow sites are our original TIDES practices.  Green sites are our matched usual care sites for the randomized substudy, WAVES.  Pale blue sites are new ReTIDES sites, representing a primary care base of potentially nearly 300,000 additional patients. The large olive green VISN, 23, has decided to spread TIDES to all of its clinics. 

QUERI Water PIPELINE

PIC, MHAP, 

MOOD,IMPACT, 

RESPECT, TEAM

Health Service Research

Implementation  Science

Implementation Policy

Depression

Care 

Guidelines

Depression

Collaborative

Care Model

Revise Guidelines

T

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W

A

V

E

S

RET

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D

E

S

C

O

V

E

S

H

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Research Methods I
        - TIDES – Quality Improvement

Expert Panel questionnaire

Depression Care Manager QI logs
        - WAVES – RCT, Site randomization

Patient structured telephone questionnaires

Patient level analysis of administrative data 

Research Methods II
        - COVES – Mixed Method Evaluation

Site level stakeholder interviews

Cost analysis
        - 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

 Method Complexity
        - Multi-level data collection 

Organizational leaders

Clinic managers

Providers 

Patients 

Administrative record abstraction. 
        - Multi-mode data collection 

Qualitative interviews

Quantitative surveys

Protocol Development

Protocol Development

Background
        - Usual challenges of multiple study sites
        - Unique Challenges (& Resources)

Multiple administrative sites

Multiple related studies

Protocol DevelopmentIndividual Studies
        - Comparison of application forms & processes across sites
        - Different protocol submission processes

Conventional approach (entire protocol)

Advantage: single submission

Disadvantage: lack of flexibility

Component approach

Advantage: flexibility in accommodating site differences and detailed description of components

Disadvantage: multiple submissions

Protocol DevelopmentMultiple Administrative Sites
        - Planning & strategizing
        - Coordinating protocol development
        - Tailoring protocols to administrative sites

Protocol DevelopmentInformed Consent Processes
        - VA Employees

Waiver of documentation

Managers

engage from the top down

inform as you go

Staff

Schedule with permission

Inform and consent

Protocol DevelopmentInformed Consent Processes (cont’d)
        - Patient recruitment across studies

Study #1: 

get permission to call back

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

Study #2:

Study information letter confirming appointment

Formal consent process at time of contact

Protocol Development:Building on Previous Studies

Following the Funding

vs.

Following the Research

Site Identification and Assessment

Site factors which impact the IRB working relationship
        - Site IRB

Familiarity with Implementation Research (IR) 

Site specific policies, procedures, forms, customs, and workload
        - Site PI 

Experience 

Professional focus (research, clinical, mixed)

Comfort level with research and IRB tasks

Local resources (time, staffing, etc)

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

Collaboration
        - Discuss in advance who is doing what 

This involves

Clarifying roles 

Deciding how tasks will be shared or delegated. 
        - Determine how (non-fiscal) research support should be centralized, local or mixed, etc.  

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

Informants

Current or potential site PIs

Local IRB staff

Colleagues at site

Electronic data sources
        - 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)

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

Establishing Relationships with Site Principal Investigators

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

HERDING CATS
          - well, not *really*
          - Lots of moving parts   

# of SITE PIs 
          - Some overlap between studies (yeah) 
          - Some changes within studies & sites due to retirement, promotion, new job/moving (not so yeah) 

CHALLENGES 
          - Identified over time, in all three studies 
          - Familiar to multi-site studies, regardless of the study type (clinical, implementation research, etc.) 

PROCESS AIDS 
          - Communication is key, #1 
          - Process aids were developed as responses to challenges, alleviating stress for both Site PIs and research team 

Multiple Local Site PI Challenges 
        - Recruitment

Finding interested & capable researchers at local sites
        - Research experience & availability

With their local IRB

Within existing commitments
        - Ethics certification 

Variability in annual deadlines 
        - Level of involvement

Sometimes connected to availability 

RECRUITMENT
          - Coordinating sites were far removed from sites where studies were implemented, minimal money for travel and meet people  
          - How to find several potential candidates with the capabilities (ready or ready to learn), time, supervisor support, and interest?  

EXPERIENCE & AVAILABILITY
          - Familiarity with IRB (from where it is located to contact personnel to general “feel”), IRB process (initial, renewals, etc.), IRB communication loop (only to Site PI or include non-local contact personnel) 
          - Include R&D process, too?
          - Competitors:  clinical obligations, other research studies, work commitments

ETHICS CERTIFICATION 
          - Required documents relatively standard (good clinical practices/human subjects, privacy/HIPAA, etc.) 
          - Time for renewal not standard, many IRBs collect that certification documentation for their records, can delay approvals 

LEVEL OF INVOLVEMENT 
          - Different participation/engagement  
          - Will they forward communication from IRB?  Walk documents around for signatures?  Responsive to email/phone messages?  Review applications prior to submission?   

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

CHARTER and MoA 
          - Clear delineation of responsibilities
          - Provide background and context to study 
          - Helpful in talking with supervisors, seeing if relevant to career goals 
          - Other helpful items: assigning 1 research team contact per Site PI.  Establish relationship, develop rapport, ensure consistency of information  

SITE PI CHECKLIST 
          - Make sure there is no misunderstandings between players 
          - What Asdf
          - Adsf

IRB DATABSE
          - Adfadff
          - Adfadf

MEETINGS, ETC 
          - Asdfadf
          - Adfadff 

Managing Multiple Sites & Systems

Interrelated projects engaging many different sites, systems and VISNs.

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

Managing a complex IRB process encompassing a multiplicity of interrelated studies involving overlapping, multiple sites, systems and networks can be a staggering challenge. Our management effort was targeted towards key multidimensional goals and supported the ultimate goal of assuring the ethical conduct of research. I will discuss the tools or process aids for each of the following goals and summarize at the end. 

Managing Multiple Sites & Systems

Goal: Maintain accountability across systems & sites

Centralize IRB documents & management at a single site 

Tools:

IRB relational database

Data management software for tracking and monitoring compliance across sites

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 

Accountability means assuring  continuity in submission and IRB interaction process by assigning responsibility to a specific person on the research team who will be accountable for carrying out all IRB activities for that site. To support and monitor that effort, we centralized IRB document storage of IRB documents which in turn helped with compliance tracking and monitoring. We entered submission and approval information in our relational IRB tracking database and used the reports it generated to track deadlines, submissions, approvals. The reports were used to inform discussions of barriers to timely submissions such as competing deadlines for the responsible staff that could impede timely submissions. 

Screen Shot of Relational IRB Tracking  Database (Access) 

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 approval

Tools:

IRB Contact Questionnaire for individual IRBs

Enter information in relational database (multiple uses)

Use IRB working group as forum for assessing strategies 

Contact questionnaire collected contact information on IRB point of contact, web site address for access to forms and instructions, submission deadlines, other information to assure compliance with each IRB’s requirements. 

Managing Multiple Sites & Systems

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

Tool: Relational database 

stores contact information, certification status

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

Database also stores action points such as tasks related to deadlines

Managing Multiple Sites & Systems 

Goal:Adherence to site-specific protocols and approval type  

Identify protocol and approval differences across sites

Tool: Relational database

records differences and generates reports

Tool: IRB working group 

uses reports to assess, track and monitor adherence across sites  

Can also mention that each site had its own folder with related docs.

Managing Multiple Sites & Systems

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 

Differences in definitions also affected reporting requirements. WE

Managing Multiple Sites & Systems
        - 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 

Managing High Risk Issues

High-risk patients in the context of implementation studies
        - High-risk veterans require special planning throughout protocol development
        - TIDES studied veterans 

With depression

Not receiving mental health care at time of study enrollment

Therefore, at high risk of suicide

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

Dialogue with IRB regarding impact on high-risk populations
        - 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

Creation of a multi-site, multi-level risk management team
        - Sites have varied resources

PI time/other commitments

Extant policies

Mental health coverage/clinical backup

Local community EMS
        - Research team creates comprehensive policy
        - Works with sites to customize for local conditions
        - May benefit sites by initiating a detailed examination of pre-existing policies

Risk management

IRBs

At-risk 

patients

Site 

Resources

Research 

team

The research team is “the strongest link”...serving the needs of at-risk patients, local IRBs, and local sites.  This diagram is an oversimplification as multiple relationships probably exist and must be managed by one or a few “point persons“ on research team

I’m thinking this ties in to Laura R’s slides about dealing with multiple PIs, multiple site policies etc.

Update on  VA Central IRB

Information Resources
        - COACH

http://www.research.va.gov/programs/PRIDE
        - 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

http://www.primr.org/

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