Transcript Shared Review Model

IRBshare Liaison
Training
Project Manager
Emily Sheffer: [email protected]
IRBshare Liaison Training Overview
•
•
•
•
Introductions
IRBshare Refresher
IRBshare Start Up Steps
The IRBshare System
Why create another joint review model?
• Flexibility in federal regulations (OHRP 45 CFR 46.114 and FDA 21 CRF
56.114)
• Institutions can use a “joint review” arrangement and “rely upon
the review of another qualified IRB…avoiding duplication of
effort”
• Lessons learned from centralized models
• Disease-specific models are inherently restrictive
• Numerous contractual agreements (i.e., study-specific MOUs) can
be burdensome
• CIRBs can have intensive startup costs and/or ongoing overhead
• CIRBs provide little flexibility for local IRBs
• Ongoing debate regarding external IRB’s ability to fully
understand local context issues
Conference Series Grant Support
• Vanderbilt awarded R13: “Novel IRB Review Models for
Efficient Multisite Review”
• Three meetings from 2011-2013
• Goal was to develop, build, and pilot new model(s) of IRB review of
multisite studies
• Multiple stakeholders
• Individuals from nearly 2/3s of the CTSAs, OHRP, FDA, NCATS
• Regulatory, legal, ethics, and clinical trial experts
• Iterative development
• Ongoing evaluation
• Start small: establish reliance for initial study review first, then
expand
IRBshare: General Features
• Universal terms of use preclude lengthy negotiations
• All institutions sign a one-time master agreement without sitespecific modifications or study-specific language
• Inclusive consortia broadens model utilization
• IRBshare network is open to any FWA-holding organization and
any area of research
• Low cost strengthens sustainability
• IRBshare network is free to join and has little to no overhead or
startup costs
IRBshare: Shared Review Model
FULL BOARD REVIEW SITE
SHARED REVIEW SITE
Local investigator submits study
to local IRB; study reviewed by
convened IRB
Local investigator submits study to
local IRB; study reviewed by local
subcommittee (>1 IRB member) using
IRBshare documents
IRBshare System
IRB Approved Documents
download
upload
Committee Responsibility:
Determine whether study meets
all federal regulatory guidelines
for approval of research (e.g., 45
CFR 46.111)
IRB application
Consent form(s)
Protocol + IB/Device Manual
Meeting minutes (redacted)
Determination letter
Subcommittee Responsibility:
Verify full board review site’s
determination + review for site’s
own local context issues
Local Context Checklist
IRBshare: Reliance Model Features
• Reliance model enables simultaneous IRB approval
• Once IRB approval uploaded to IRBshare, all study sites can seek approval
• Flexible reliance options support local autonomy
•
•
•
•
“Lead” IRB established organically on study-by-study basis
Studies may have more than one “lead” IRB
IRBs always have the option to review study locally
Local submission processes and forms do not have to change
• Dynamic IRB responsibilities address local IRB oversight concerns
• Local context review is always the responsibility of the local IRB
• Local IRB regains study oversight after relying on Full Board Review Site
• All study-related events are reported locally, with study-wide issues also
reported broadly via the mechanism established for the study
• Shared IRB documents minimize submission requirements at local
IRBs
• Once IRB approval documents uploaded to IRBshare, local IRBs can accept
shortened IRB applications (e.g., local context only) from local investigators
IRBshare: Additional Features
• Transparency enables continuing education and dialogue
• Sharing IRB documentation enables continuing education and
dialogue between IRBs
• Shared documents creates opportunity to utilize shared expertise,
consult other IRBs, and promote consistency in the IRB review
process
Who can use IRBshare?
• Any institution with a Federalwide Assurance with OHRP (i.e., most
institutions)
• Any industry-sponsored or investigator-initiated multi-site study
• Any number of institutions (>1 up to ∞)
• Greater than minimal risk studies (i.e., full board review required)
Participating Institutions (n=36)
Baystate Health*
University of Alabama Birmingham*†
Boston University Medical Center*†
University of Arkansas for Medical Sciences*†
Children’s National Medical Center*†
University of California San Diego†
Duke University*†
University of Illinois Chicago*†
Maine Medical Center*
University of Iowa*†
Marshall University*
University of Kansas*†
Medical University of South Carolina*†
University of Kentucky*†
Meharry Medical College†
University of Miami†
Mississippi State University*
University of Minnesota*†
Mount Sinai Medical School*†
University of North Carolina at Chapel Hill *†
New York University School of Medicine*†
University of Pittsburgh*†
North Shore LIH Health System
University of Southern California*†
Seattle Children’s Hospital
University of Texas HSC at San Antonio*†
Stanford University*†
University of Texas Southwestern Medical Center†
The Scripps Research Institute†
University of Washington†
The University of Utah*†
Vanderbilt University*†
Tufts Medical Center†
Virginia Commonwealth University*†
Tufts University †
Washington University (St. Louis) *†
*AAHRPP accredited; †CTSA institution or affiliate
Preliminary Results
• 4 active studies with shared reviews conducted
o ISCHEMIA Trial: Duke relied on Vanderbilt
o Days from Submission to Approval: 6
o MENDS II: Baystate relied on Vanderbilt
o Days from Submission to Approval: 42
o Vitamin D & Type 2 Diabetes: MUSC relied on Tufts
o Days from Submission to Approval: 27
o Neonatal Abstinence Syndrome Study: Vanderbilt relied on Tufts
o Days from Submission to Approval: 16
User Experience
• Sites showing willingness to be transparent
o 5 institutions have uploaded IRB approvals to IRBshare
• Process improvement
o Sites are modifying their processes based on those of other sites
o Institutions are thinking of how they can streamline their local
submission processes
• Shared review process said to be simple and easy to
implement
• The word is spreading!
o PIs are approaching IRBshare regarding their awarded multisite
studies and responses to RFAs
o Funding agencies are recommending use of IRBshare (“or other
centralized models”) in RFAs
What’s Next for IRBshare
• Continue effort to include continuing reviews and
amendments
• Include expedited studies
• Leverage the “IRBshare Network” to spread best practice
and determine other ways to create efficiencies in IRB
processes
• Share SOPs
• Streamline PI submission process
• Increase utilization: more institutions + more studies
• Evaluate IRBshare
•
•
•
User Satisfaction
Efficiency
Implementation
IRBshare Start Up Steps
• Inform local IRB staff and members (see checklist)
• Educate investigators and study teams
• Presentation, brochures, and PI checklist available here
• Modify IRB SOPs
• Determine how to facilitate the use of IRBshare
• Sample SOPs on Resource Page available here
• Encourage neighboring institutions to join
• IRBshare Project Manager can provide materials or a webinar
• Connect with other IRBshare Liaisons (here)
• Set goals for your IRB
• IRBshare launch date
• Deadlines for educating staff
• Workgroups to discuss streamlining submission processes
IRBshare System
IRBshare.org
• IRBshare Dashboard
• Common system actions
•
•
•
•
•
•
Logging in
Adding users
Searching for projects
Registering my site in a study
Editing review information
Uploading full board review documents
Screenshots of
IRBshare System
View in Slideshow mode to see animations
IRBshare System: Liaison Dashboard
IRBshare System: Logging In
IRBshare System: Adding Users
IRBshare System: Searching for Projects
IRBshare System: Registering My Site for
a Study
Federally-funded studies:
Any institution in IRBshare can
register for a federally-funded
study. To register, search for the
study and click on the title
If your institution is not yet registered,
you will see a popup when you click
on the title. The popup asks you to
verify that your institution
is participating in
the study.
IRBshare System: Registering My Site for
a Study
Consortium-Specific Studies
If your institution belongs to the
consortium related to the study you
select, you will be prompted to register
for the study—and acknowledge your
institution is participating in the study—
before you are able to access the project
page.
If your institution is not a member of the
consortium related to the study, or this
has not been noted in IRBshare by the
Administrator, you will see the following
popup if you click on the consortiumspecific study.
IRBshare System: Editing Review Info
IRBshare System: Uploading Full Board
Review Documents
IRBshare System: Create a New Project