IRBshare: Streamlining IRB
Review of Multisite Studies
E M I LY S H E F F E R , M PA | V A N D E R B I LT U N I V E R S I T Y M E D I C A L C E N T E R | E M I LY. S H E F F E R @ I R B S H A R E . O R G
IRBshare Background
Funded by National Center for Research Resources
(NCRR) (2011-2014)
Initial Project Goals
◦ Maintain high level of protection for human subjects in
multicenter trials
◦ Accelerate study start Up
◦ Create a scalable IRB reliance model (minimal funding
required; open to all institutions)
◦ Create transparency between IRBs to promote shared
expertise and practices
>30 Institutions
CTSA Leadership,
IRB Directors,
Lawyers, Clinical
Trial Experts
Regulatory
Expertise
OHRP,
AAHRPP, WIRB
Sponsors
Eli Lily, NIH, VA
Shared Review Model
Initial Study Review
Continuing Review
Study-wide amendments
LEAD IRB
LOCAL OVERSIGHT IRB
1. Local investigator submits study to
local IRB
2. Study reviewed according to risk level
(expedited or full committee review)
1. Local investigator submits study to
local IRB (abbrev application recommended)
2. Study reviewed by local
subcommittee (>1 IRB member) using
IRBshare documents
BUSINESS
AS USUAL
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
download
IRB application
Consent form(s) (become model consent(s))
Protocol + IB/Device Manual
Meeting minutes (redacted)
Determination letter
Subcommittee Responsibility:
1. Verify (not re-review) Lead IRB’s
determination, AND
2. Review for site’s own local context
issues
LOCAL IRB MAINTAINS OVERSIGHT
STEP 1: Lead IRB identified
by PIs and/or sponsor or
funder.
Lead IRB may be
• 1st IRB with approval
• IRB of Overall Study PI
AND should be a site at
which all or most study
activities occur
IRBs
Study Teams
Initiating Use of IRBshare
STEP 2:
Site PI contacts
IRBshare
Liaison* with
request to be
Lead IRB
NO
Alternative
Lead IRB
Identified
STEP 3: PI at
Lead IRB
submits study
to Local IRB
AS USUAL
YES
*IRBshare Liaisons
are the primary IRB
contact at each site
Study PIs discuss
alternative Lead
IRB options with
other IRBs, if any.
STEP 4a: Notify* other site PIs with
instructions to:
• Ask local IRB about submission
procedures (e.g., use of abbreviated
application);
• Wait to submit to their IRB until Lead
IRB PI shares approved Informed
Consent Form (ICF)
*Whoever is coordinating study (e.g.,
Coordinating center, CRO, PI at Lead IRB, etc.)
STEP 4b: Lead IRB
reviews study as
usual
STEP 5: Lead IRB
approves study,
notifies Lead PI as
usual, and uploads
approval to
IRBshare System.
STEP 6:
Approved ICF
sent to other
sites (by same
entity as used in
4a)
STEP 7: Local PIs
submit to their
Local IRB, following
their local
submission
guidelines for
IRBshare (see 4a).
ALL SITE PIs report local
modifications, AEs,
unanticipated problems,
etc. to local IRB. Follow
protocol regarding adverse
event reporting to other
sites. Repeat Steps 3-9 for
continuing review and
study-wide amendments.
STEP 8: Local IRBs
use Shared Review
Process to approve
study and note
reliance on Lead
IRB’s approval in
IRBshare System.
STEP 9: Local IRBs send
approval letter to local
investigator (note: letter
may note of IRBshare).
Local IRB remains IRB of
record for local PI.
IRBshare is NOT a Central IRB
How is it different?
◦ Single IRB Review vs. Single IRB of Record
◦ One review of criteria for approval of research
◦ Local context is reviewed by each local IRB
◦ IRBshare does not change to whom investigators submit and report: Always
the Local IRB
◦ Lead IRB grants approval for it’s local site only
◦ Lead IRB does not receive submissions from all site investigators
Benefits for Investigators
Accelerate study start up by avoiding multiple full committee reviews
No budget required (many central IRBs require significant start up and operational
funds)
Fewer interactions and requests for changes from IRB
Streamlined initial IRB submission for relying IRBs (per local IRB policy)
Each investigator only reports to one IRB—their local IRB
Preliminary Results and
Lessons Learned
IRBSHARE MASTER AGREEMENT FINALIZED: OCTOBER 2012
FIRST RELIANCE: FEBRUARY 2013
IRBshare Scope and Eligibility
Institutions
Any institution with an FWA and federally constituted IRB
AAHRPP not required, but captured for relying sites’ decision making
Studies
All studies that require IRB review
All diseases and conditions
All funders: Federal, industry, and investigator-initiated
IRB Reviews Included
All Phase of Review: Initial study review, continuing review, and reviews
of amendments
IRBshare Successes
National Reliance Model:
◦ 65 institutions in 30 states have executed single master reliance agreement
◦ No funding required to support use
Accelerating Study Start Up: Median of 14 days from submission to approval (n=42
reliances; 65% studies are greater than minimal risk)
Transparency
◦ Shared Expertise—Institutions unable to transfer oversight can streamline their review
◦ Shared Practices—IRBs communicating and sharing documents/templates
IRBshare Network (n=65)
Baylor Research Institute*
Ohio University
University of California, San Francisco*†
Baystate Health*
Oregon Health & Science University†
University of Cincinnati*†
Boston University Medical Center*†
Ochsner Health System*
University of Illinois Chicago*†
Children’s National Medical Center*†
Pennington Biomedical Research Center*
University of Iowa*†
Cincinnati Children’s Hospital Medical Center*†
St. Claire Regional Medical Center
University of Kansas*†
Columbia University*†
Seattle Children’s Hospital
University of Kentucky*†
Duke University*†
Stanford University*†
University of Miami*†
Louisiana State University A & M*
Sutter West Bay Hospitals
University of New Mexico Health Sciences Center*†
Indiana University*†
Texas A&M University*
University of North Carolina at Chapel Hill *†
Louisiana State University HSC New Orleans*
The Rockefeller University*†
University of Pennsylvania*†
Louisiana State University HSC Shreveport*
The Scripps Research Institute†
University of Pittsburgh*†
Maine Medical Center*
The University of Arizona*
University of Southern California*†
Marshall University*
The University of Texas HSC at Houston*†
University of Texas HSC at San Antonio*†
Medical University of South Carolina*†
The University of Utah*†
University of Texas Southwestern Medical Center†
Mayo Clinic*†
Tufts Medical Center†
University of Washington†
Meharry Medical College†
Tufts University †
Vanderbilt University*†
Michigan State University*
Tulane University*
Virginia Commonwealth University*†
Mississippi State University*
University of Alabama Birmingham*†
Wake Forest University Health Sciences*
Mount Sinai Medical School*†
University of Arkansas for Medical Sciences*†
Washington University (St. Louis) *†
New York University School of Medicine*†
University of California, Davis*†
West Virginia University*
North Shore LIH Health System
University of California, Los Angeles†*
Xavier University (Louisiana)
Northwestern University †
University of California, San Diego†
*AAHRPP accredited (n=50); †CTSA institution (n=43)
States (n=30):
Alabama
Arizona
Arkansas
California
Florida
Illinois
Indiana
Iowa
Kansas
Kentucky
Louisiana
Maine
Massachusetts
Michigan
Minnesota
Mississippi
Missouri
New Mexico
New York
North Carolina
Ohio
Oregon
Pennsylvania
South Carolina
Tennessee
Texas
Utah
Virginia
West Virginia
Washington
(Washington DC)
Using IRBshare
Initiating Use of IRBshare
1.
Identifying a Lead IRB
◦
◦
2.
Investigator at Lead IRB approaches IRB
◦
◦
3.
Request to use IRBshare and be Lead IRB
No change to submission process for investigator at Lead IRB
While the Lead IRB seeks approval…
◦
◦
4.
Recruit non-IRBshare sites (ask Investigator at site to approach IRB)
IRBshare site investigators notify IRB liaison (here) and ask about submission procedures (e.g., short form application
available?)
Once Lead IRB has approval, disseminate (see next slide) approved documents to other study sites
◦
5.
Naturally occurring (e.g., 1st with IRB approval)
Select IRB based on experience, IRB willingness, site visit schedule
Approved consent becomes model consent
Other site investigators insert local language into model consent and submit to their IRB as directed (see
step 3)
Coordinating Use of IRBshare
1. Investigators at each site ONLY submit to their local IRB.
2.
The investigator at the Lead IRB should always submit in a timely manner to their IRB
3.
Initial Review:
◦
◦
The study should be submitted to the Lead IRB as soon as the protocol is finalized. All potential study sites do
not have to be identified before the study is submitted for initial approval.
Study documents should be disseminated to the other sites as it would have without IRBshare. (e.g., a
coordinating center or sponsor or clinical research organization (CRO), or the investigator if no coordinating
mechanism exists)
4.
Continuing Review: Lead investigators should submit at least 8 weeks prior to their expiration date to
ensure the IRB has time to review, approve and upload it to IRBshare for other IRB’s to utilize to streamline
their review.
5.
Study-wide Amendments: Lead investigator submit as soon as the change is finalized and disseminate
documents to other sites as soon as approval is received. (Note: amendments for safety reasons may need
further discussion)
6.
Local Amendments: do not get uploaded to IRBshare as they are site-specific and do not require review by
each IRB, only the local IRB.
https://IRBshare.org