IRBshare Overview: IRBs
Emily Sheffer, MPA
Vanderbilt University Medical Center
IRBshare Project Manager
[email protected] | 615-343-2384
IRBshare Overview
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Background
The Shared Review Model
Process for Using IRBshare
Benefits of IRBshare
Current Progress
Next Steps
IRBshare Background
• Developed with funds from
NCRR/NCATS conference series grant
(PI – Bernard)
• Involved diverse experts from across
the US
• Developed over three years (20112014)
• Based on lessons learned from other
streamlining models (central IRBs,
independent IRBs, ceded reliance
agreements)
Institutional
Representatives
CTSA Leadership,
IRB Directors,
Lawyers, Clinical
Trial Experts
Regulatory
Expertise
OHRP, AAHRPP,
WIRB
Sponsors
Eli Lily, NIH,
VA
The Shared Review Model
IRBshare Shared Review Model
LEAD IRB
LOCAL OVERSIGHT 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
3. Document reliance on Lead IRB’s
review via IRBshare System.
Local Context Checklist
After using the Shared Review
• Local Oversight IRB inherits expiration date of Lead IRB
• Local Oversight IRB is the IRB of record for their site until the
next review
• All events and protocol deviations are reported locally
• Study-wide issues are reported across sites as stipulated by the
protocol/sponsor
IRBshare-related Process Changes (in red)
Pre-Submission
Pre-Review
Review
Post-Review
Lead IRB
Lead site
determined by
sponsor +
investigators + IRB
Follow local policies and
procedures
Follow local policies and
procedures
• Follow local IRB policies
• Redact meeting minutes
(if not written in
redacted fashion)
• Upload approval
documents to IRBshare
Local
Oversight IRB
(relying site)
Discuss appropriate
submission process
when using
IRBshare (modified
submission
possible!)
• Shortened pre-review:
• Verify approved
application of Lead IRB
• Check for local context
information
• Optional: Add “flag” to
study in internal database
to show (1) IRBshare study
+ (2) Lead IRB (e.g.,
“IRBshare – UCSD”)
• Download Lead IRB’s
approval documents
accessed via IRBshare
• Reviewer Completes
Review
• Document
comments/concerns
• Verify agreement with
Lead IRB determination
• Document approval of
local context
• Document risk, review
cycle, and expiration if
approved
• Enter determination +
approval status + risk
level + approval and
expiration dates
• Send letter documenting
use of IRBshare
Benefits of IRBshare
Streamline IRB review while maintaining local oversight
• Minimal process change and burden for the Lead IRB
• Reduce analyst time in pre-review by utilizing a local abbreviated
application and the full, approved IRB application for Lead IRB
• Avoid duplicative IRB reviews AND maintaining local oversight
• IRBshare involves MINIMAL CHANGES to current processes
Benefits of IRBshare
Promote transparency, consistency and education among IRBs
• IRBs share their approval documents with other IRBs (only) that may
increase review quality
• Promotes consistency in IRB determinations
• Encourages communication and education between IRBs
• Mechanism for receiving collaborative, non-punitive feedback on
reviews
Benefits of IRBshare
Scalability
• 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
• Minimize the number of external agreements each IRB has to
maintain
• Available to studies at any level of review (expedited or full
committee)
Benefits of IRBshare
Mechanism to streamline submission for investigators
• Full applications are submitted to the Lead IRB
• Local IRB only needs to submit local context issues + local consent
form
Current Progress
IRBshare Pilot Phase (February 2013- December 2014)
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
• 9 studies have had at least 1 reliance
• 13 reliances to date (4 in Year 1; 9 in Year 2)
• Turnaround Time
• Median of 20 days from IRB submission to approval
• Median of 1 day from IRB review to approval
Download

Overview Presentation