Overview Presentation

Report
IRBshare Overview:
Investigators
Emily Sheffer, MPA
Vanderbilt University Medical Center
IRBshare Project Manager
[email protected] | 615-343-2384
IRBshare Background
• Developed with funds from
NCRR/NCATS conference series grant
(R13; PI – Bernard)
• Developed over three years (20112014) based on lessons learned from
other streamlining models (central
IRBs, independent IRBs, ceded
reliance agreements)
• Involved diverse experts from
different organizations (see image)
Institutional
Representatives
CTSA Leadership,
IRB Directors,
Lawyers, Clinical
Trial Experts
Regulatory
Expertise
OHRP, AAHRPP,
WIRB
Sponsors
Eli Lily, NIH,
VA
What is IRBshare?
• Joint IRB review model (45 CFR 46.114) that reduces duplicative
IRB reviews of multisite studies for faster study start up
• Mechanism to streamline study submissions for investigators
• Mechanism to increase transparency between IRBs by facilitating
the sharing of approval documents to facilitate more consistent
IRB reviews, high quality reviews, and promote best practices.
IRBshare Shared Review Model: IRBs
LEAD IRB
LOCAL/RELYING IRB
1. Local investigator submits study
to local IRB
2. Study reviewed by convened IRB
1. Local investigator submits study to
local IRB (perhaps abbrev forms)
2. Study reviewed by local
subcommittee (>1 IRB member)
using IRBshare documents
IRBshare System
upload
Committee Responsibility:
1. Determine whether study
meets all federal regulatory
guidelines for approval of
research (e.g., 45 CFR 46.111)
IRB Approved Documents
IRB application
Consent form(s)
Protocol + IB/Device Manual
Meeting minutes (redacted)
Determination letter
download
Subcommittee Responsibility:
1. Verify Lead IRB’s determination,
AND
2. Review for site’s own local
context issues
Why IRBshare?
Increase Reliance Opportunities Nationwide
• Free to join and use
• Open to any institution with a Federalwide Assurance (FWA) with
OHRP
• Single reliance agreement allows use with any multisite study
regardless of disease type and funding support
• Available to studies at any level of review (expedited or full
committee)
• IRBshare can facilitate consortium-specific groups and studies
Using the Shared Review Model
Prior to Study Initiation
Identify Potential Lead
IRBs based on discussions
with sponsor/funder +
investigators + IRB
Investigators at IRBshare
sites should inquire about
modified IRB submissions
when their site is relying on
another IRB via IRBshare
Investigators at nonIRBshare sites should
request that their
institution join IRBshare
1. Investigator Seeks Approval from Lead IRB
IRB Process:
Lead IRB processes
study according to
level of review
required
(expedited/full)
Lead IRB approves
based on the federal
regulatory guidelines
for approval of
research
Investigator at “Lead
IRB” site submits study
to local IRB per local IRB
policies
Lead IRB uploads
approved documents
to IRBshare for other
IRBs to access
2. Disseminate Study Documents for Local
Submission
Coordinating center, lead PI, or sponsor
disseminates study documents, including
consents, to aid local IRB submission
3. Local Investigators Submit Study to Local
IRBs
IRB Process:
Local IRB accesses shared
approval documents via the
IRBshare System
Local IRB subcommittee uses
Shared Review to verify 1)
agreement with Lead IRB’s
determination + 2) local
context issues
Local investigators request use of modified IRB
submission (local context info + consent form)
because a full IRB Application was completed by
the investigator at the Lead IRB site.
If approved, local site inherits
expiration date of Lead IRB +
resumes study oversight. If not
approved, study reviewed
according to local policy.
After Using the Shared Review
• IRB:
• Lead IRBs and Relying IRBs are each responsible for their own local oversight
• Relying IRB inherits expiration date of Lead IRB
• Study Teams:
• All events and protocol deviations are reported to local IRB
• Study-wide issues are reported across sites as stipulated by the
protocol/sponsor
• Submit amendments and continuing reviews to local IRB per local IRB
policies (local IRB will use IRBshare as applicable)
IRBshare Progress to Date
IRBshare
Network
(n=52)
*AAHRPP accredited
†CTSA institution
Baystate Health*
The University of Utah*†
Boston University Medical Center*†
Tufts Medical Center†
Children’s National Medical Center*†
Tufts University †
Columbia University*†
Tulane University*
Duke University*†
University of Alabama Birmingham*†
Louisiana State University A & M*
University of Arkansas for Medical Sciences*†
Louisiana State University HSC New Orleans*
University of California San Diego†
Louisiana State University HSC Shreveport
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†
Michigan State University*
University of Minnesota*†
Mississippi State University*
University of New Mexico Health Sciences Center*†
Mount Sinai Medical School*†
University of North Carolina at Chapel Hill *†
New York University School of Medicine*†
University of Pennsylvania*†
North Shore LIH Health System
University of Pittsburgh*†
Northwestern University †
University of Southern California*†
Pennington Biomedical Research Center*
University of Texas HSC at San Antonio*†
St. Claire Regional Medical Center
University of Texas Southwestern Medical Center†
Seattle Children’s Hospital
University of Washington†
Stanford University*†
Vanderbilt University*†
The Rockefeller University*†
Virginia Commonwealth University*†
The Scripps Research Institute†
Wake Forest University Health Sciences*
The University of Arizona*
Washington University (St. Louis) *†
The University of Texas HSC at Houston*†
Xavier University (Louisiana)
States (n=26):
Alabama
Arizona
Arkansas
California
Florida
Illinois
Iowa
Kansas
Kentucky
Louisiana
Maine
Massachusetts
Michigan
Mississippi
Minnesota
New Mexico
New York
North Carolina
Pennsylvania
South Carolina
Tennessee
Texas
Utah
Virginia
West Virginia
Washington
(Washington DC)
Preliminary Results
• First reliance: February 2013
• Site Usage:
• 11 sites have uploaded their approval
• 8 sites have relied upon another IRB’s review
• Studies in IRBshare
• 13 studies added to IRBshare (4 added in Y1; 9 added in Y2)
• 9 studies have had at least 1 reliance
• 13 reliances to date (4 in Y1; 9 in Y2)
• Turnaround Time
• Median of 20 days from IRB submission to approval
• Median of 1 day from IRB review to approval
Contact Information
• IRBshare Project Manager
• Emily Sheffer | Vanderbilt University | [email protected] | 615343-2384
• Local IRBshare Liaisons
• Found on the IRBshare website (https://IRBshare.org) under “Participating
Institutions”

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