Multi-Institutional Facilitated IRB Review

Philip A. Cola, MA Vice President, Research and Technology University Hospitals Case Medical Center

 

Third Annual Clinical Research Management WorkshopJune 22, 2010

Kathleen Lawry, MSSA, CIP, CIM, Assistant Director Research

Administration MetroHealth Medical Center

Multi-Institutional Facilitated IRB Review

• 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

Background

• 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

Multi-Institutional Facilitated IRB Review

Background Continued…

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.

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

Leveraging Electronic Systems for Facilitated Review (FR)

Facilitated ReviewMethodology

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 ReviewMethodology (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

PI Requests Facilitated Review by Named IRB(s)

Uploads Study Documents to HUB and Completes Site

Specific forms

Named IRB

Reviews Study

Named IRB Approves Study

Named IRB Disapproves Study

for Facilitated Review

PI Uploads all Continuing Reviews, Amendments,

Un-anticipated Problems for the life of the study

Named IRB Reports to Named IRB(s) any

Suspensions, Complaints or

Compliance Issues

PI Requests Full Board or Expedited Review

by Named IRB

Contact Information

Kathleen Lawry, MSSA, CIP, CIMInstitutional Review Board ManagerAssistant Director, Research Administration-ComplianceMetroHealth Medical Center2500 MetroHealth DriveCleveland, Ohio 44109-1998216-778-2077 (Office) email: klawry@metrohealth.org

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 Philip.Cola@uhhospitals.org