Transcript IRBshare: Streamlining IRB Review for Multi

IRBSHARE: STREAMLINING
IRB REVIEW FOR MULTISITE STUDIES
BACKGROUND
The need to streamline IRB review
IRBshare Development Considerations
• 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
THE IRBshare MODEL
How IRBs use IRBshare
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
upload
Committee Responsibility:
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:
Verify full board review site’s
determination + review for site’s
own local context issues
IRBshare Information Flow for Multicenter
Study
Study Coordinating
Center (CC)
(e.g., CRO, lead site)
CC disseminates studyrelated materials and updates
Local investigator reports
adverse events/unanticipated
problems to local IRB, and
then the CC
(if necessary)
Local investigator submits to
local IRB, who can then
download IRB approval
documents from IRBshare and
review and approve the study
via a local subcommittee. No
documents are uploaded to
IRBshare by the Shared
Review Sites. The direction of
the arrows is indicative of the
information flow.
Local
Investigator,
Institution A
Local
Investigator,
Institution B
Discuss, review, and
approve changes to the
protocol, Investigator
Brochure and/or Device
Manual based on reported
events/problems
Local
Investigator,
Institution C
Local IRB
Local IRB
Local IRB
IRBshare
Web-based
System
DSMB
Local IRB--now a
Full Board Review
Site--uploads IRB
approval
documents to
IRBshare
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
IRBshare TO DATE
October 2012 to present
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)
IRBshare Network (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
•
Regulatory Acknowledgement (OHRP, FDA, AAHRPP)
• 4 active studies with shared reviews conducted
•
ISCHEMIA Trial: Duke relied on Vanderbilt
•
•
MENDS II: Baystate relied on Vanderbilt
•
•
Days from Submission to Approval: 42
Vitamin D & Type 2 Diabetes: MUSC relied on Tufts
•
•
Days from Submission to Approval: 27
Neonatal Abstinence Syndrome Study: Vanderbilt relied on Tufts
•
•
Days from Submission to Approval: 6
Days from Submission to Approval: 16
Recommended use mentioned in federal RFAs
•
Recent U54 Rare Disease RFA stated that “applicants are strongly
encouraged to consider models that will facilitate “shared review”
such as IRBshare or a central IRB of record for multisite trials and
provide plans for implementation.”
IRBshare FOR STUDY TEAMS
AND INVESTIGATORS
Applying for a multicenter grant?
1. Utilize the grant template language
IRBshare.org/#resources
2. List the # of study sites in IRBshare
3. Recruit non-IRBshare sites
a) Ask site PIs to email their IRB Director re: IRBshare and
CC: [email protected]
b) Email [email protected]
i. Study title
ii. Study sites
iii. Site PI names and emails
iv. IRB Director names and emails
c) IRBshare can help reach out to site IRB Director(s)
Want to encourage an institution to
join IRBshare?
• Encourage your colleagues at other institutions to
talk to their IRB Director about IRBshare
• Sites join by having their Institutional Official sign
the IRBshare Master Agreement (IMA)
• CC [email protected]
Not sure if a study is in IRBshare?
• Visit https://IRBshare.org/#studies
• Contact your IRBshare Liaison
(https://IRBshare.org/#participants) or email
[email protected]
Lead site for a multi-site study?
• Notify your IRBshare Liaison ASAP
(https://IRBshare.org/#participants)
• Submit a cover letter with your IRB submission
• Tell collaborating PIs to contact their IRBshare liaison
ASAP
Participating in study that has IRB
approval in IRBshare?
• Contact your IRBshare liaison ASAP
• Submit your IRB application as usual to your IRB
• Include a cover letter indicating that an approval is in
IRBshare
IRBshare Checklist for Study Teams
https://www.ctsacentral.org/editor/index.php?doc_id=3843
IRBshare FOR INDUSTRY
SPONSORED STUDIES
Ensure Proper Access to Study Documents
Overview
• IRBshare can be used with industry sponsored study with
the approval of the sponsor
• IRBshare will obtain study sites from the sponsor and
enable only IRBs at those sites to view study documents.
• Sites can be added/removed as needed
Creating Industry-Sponsored Studies
If sponsor isn’t listed in IRBshare…
• IRBshare users can request
that new sponsors be
added
• IRBshare administrator will
contact sponsor to verify
study should be added to
IRBshare + confirm study
sites
Access to Industry-sponsored Studies is
Limited
• IRBshare
administrator can
quickly and easily
• indicate which
IRBshare institutions
are study sites
• remove sites that drop
from the study, as
directed by Sponsor