Multi-Institutional Facilitated IRB Review

Report
Multi-Institutional Facilitated IRB Review
Third Annual Clinical Research Management Workshop
June 22, 2010
Kathleen Lawry,
MSSA, CIP, CIM,
Assistant Director Research
Administration MetroHealth Medical
Center
Philip A. Cola, MA
Vice President, Research and Technology
University Hospitals Case Medical Center
Multi-Institutional Facilitated IRB Review
Background
• The Clinical Translational Science Collaborative (CTSC) in
Cleveland, Ohio has endorsed process improvement in
clinical research management as a high priority
• Initial process improvement initiative was the
development and implementation of a “facilitated
review” process (FR)
 to facilitate the conduct of research within four legally separate
institutions in a manner that reduces investigator burden while
maintaining the integrity of the IRB review
Multi-Institutional Facilitated IRB Review
Background Continued…
• Prior to this initiative, investigators at each of the
separate legal entities were required to submit common
research protocols to each site’s IRB for review and
approval
• A process was created to allow studies approved by one
institution to receive FR via an newly created electronic
“HUB” at the other participating institution(s)
• Process relies on executed Inter-Institutional
Agreements (IIAs) among separate institutions that
share investigators and protocols
Facilitated Review
Process Overview
• The design allows Institution A to act as the IRB of
record and review collaborative studies according to
all applicable regulatory standards (federal, state &
local)
• IRB at Institution B (Named IRB) affirms the review
by conducting a “local context” review of the protocol
to ensure institutional “local” compliance
 Approved study documentation including adverse event,
unanticipated problem, and deviation reports, amendments
and continuing reviews are uploaded and maintained in the
HUB, accessible to all participating institutions.
Leveraging Electronic Systems for
Facilitated Review (FR)
FR allows investigators to make a single IRB submission for
multiple reviews within the Cleveland CTSC
The “HUB” allows all IRBs named in application to:
• access complete and updated study files for the life cycle of
a study including correspondence and reviews
• customize forms for each participating IRB
• perform parallel reviews of projects
• Efficient communication between IRBs and investigators
Facilitated Review
Methodology
Key elements:
• A single IRB submission to the IRB of record
• Electronic HUB with all study documents and
reviews from IRB of record.
• Brief site specific application form and review form
for all named IRB(s)
• Online review by all named IRB(s) with the ability to
request additional information
• Site specific forms
Facilitated Review
Methodology (continued…)
Process Flow:
•
Each Named IRB decides whether or not to accept a
protocol for Facilitated Review
•
Each Named IRB retains control over their own process for
performing a local context review and the design of their
own review forms
•
If there are no concerns about local context, the Chair (or
subcommittee) may decide to accept the review, of the IRB
of Record
•
The IRB of record performs all future continuing reviews,
amendment reviews and reviews of unanticipated problems
for the life of the study
Oversite for the Named IRB(s)
Studies Approved Utilizing Facilitated Review:
• The HUB is updated with all continuing reviews,
amendment reviews and reviews of unanticipated
problems and all named IRB(s) are notified electronically
and can review these documents thus retaining continuous
oversite
• All unanticipated problems, complaints and or suspensions
are reported to the named institution(s) electronically via
the HUB
Flow Chart Facilitated Review
Study is
Approved
By Named
IRB
Named IRB
Approves Study
PI Uploads all Continuing
Reviews, Amendments,
Un-anticipated Problems
for the life of the study
PI Requests Facilitated
Review by Named IRB(s)
Named
IRB
Reviews
Study
Named IRB Reports to
Named IRB(s) any
Suspensions,
Complaints or
Compliance Issues
Uploads Study Documents
to HUB and Completes Site
Specific forms
Named IRB
Disapproves Study
for Facilitated
Review
PI Requests Full Board
or Expedited Review
by Named IRB
Contact Information
Kathleen Lawry, MSSA, CIP, CIM
Institutional Review Board Manager
Assistant Director, Research Administration-Compliance
MetroHealth Medical Center
2500 MetroHealth Drive
Cleveland, Ohio 44109-1998
216-778-2077 (Office) email:
[email protected]
Philip A. Cola, M.A.
Vice President, Research and Technology
University Hospitals Case Medical Center
11100 Euclid Avenue
Cleveland, Ohio 44106-7061
Phone: (216) 844-5576
Fax: (216) 844-1547
[email protected]

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