IRBMED AND
CHESAPEAKE IRB
• General Procedures for Ceding IRBMED Oversight
• Procedures Specific to Chesapeake IRB
Medical School
Institutional Review Board (IRBMED)
Introductions
Representatives

Chesapeake

IRBMED
Medical School
Institutional Review Board (IRBMED)
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What is a central IRB?
Central IRB – A single IRB that provides regulatory
and ethical review services for multiple sites
participating in a research study
A central IRB may be independent (sometimes
called commercial) or institutional
 Independent IRB – Chesapeake IRB
 Institutional IRB – University/Hospital IRB
Medical School
Institutional Review Board (IRBMED)
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What does it mean to cede oversight?
Ceding is a legal agreement that transfers
responsibilities from one entity to another
To cede oversight of the ethical review of research,
IRBMED must agree to relinquish certain
responsibilities and Chesapeake IRB (for example) must
agree to assume those responsibilities
 IRB Authorization Agreement – IRB regulatory terms
 Master Service Agreement – All other contractual terms and
responsibilities
Medical School
Institutional Review Board (IRBMED)
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What are the benefits to ceding IRB
oversight?
 FDA, OHRP, NIH, and U-M all support the use of central IRBs to
improve the efficiency of conducting multi-site trials
 Enhance research partnerships
 Industry - sponsored research
 Cooperative group research
 Inter-institutional academic relationships
 Ensure consistency between investigative sites by utilizing a single
IRB
 Avoid individual reviews by local IRBs
 Respond to faculty needs
Medical School
Institutional Review Board (IRBMED)
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U-M Plans and Roll-out
The process is in early stages of roll-out
 Completed roll-out in approximately 6 months
U-M plans to seek Master Service Agreements with
appropriately qualified central IRBs
 Each central IRB may have slightly different procedural elements
relationships
 The first application for each new central IRB will take add’l time
A new eResearch application type was developed for
use by the UMHS/medical school community
 Guidance materials are in development
Medical School
Institutional Review Board (IRBMED)
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How do study teams at U-M utilize a
central IRB?
1) As part of the PAF Application, indicate from the
drop-down listing which central IRB will be used to
ensure that appropriate contractual terms are added
2) Complete the eResearch application “Requesting
Review by a Non-UM IRB” (aka Ceding)
3) The ceding application will be reviewed by the
ancillary committees and acknowledged by IRBMED
Medical School
Institutional Review Board (IRBMED)
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Generic Workflow
Identify the
Central IRB in the
PAF
Initiate a U-M
IRBMED Ceding
Application
Initiate the
Central IRB
application
Medical School
Institutional Review Board (IRBMED)
UM Ancillary
Committee
Reviews
IRBMED
Acknowledgement
Submit the
Central IRB
application
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Sections of the Ceding Application
1
General Study Information
2
Sponsor Information
3
UM Study Functions
4-3 Requesting Review by Non-UM IRB
5-2/4 Research Design
6-2 Benefits and Risks
7-3 Special Considerations
8
Subject Participation
9-3 Subject Populations
10-6 Informed Consent
11 Confidentiality/Security/Privacy
13 Subject Payment
14 Health Care Treatments and Procedures
Medical School
Institutional Review Board (IRBMED)
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Terms of the Master Agreement
UM
Chesapeake IRB
 Conflict of Interest
 IRB Application
 Investigational Drug Service
 Protocol
 RDRC/SHUR
 Informed consent
 CRAO
 Recruitment
 Protocol Review Committee
 All other relevant materials
 (Cancer Center)
 IRBMED Acknowledgement
Medical School
Institutional Review Board (IRBMED)
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THANK YOU!
Additional questions will be answered
following the Chesapeake IRB presentation
Medical School
Institutional Review Board (IRBMED)
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Questions & Answers
 How long will it take for ancillary committee review to be
completed? Ancillary review remains unchanged.
 How long will it take for an IRBMED acknowledgement
letter to be issued? Following review by ancillary
committees, IRBMED acknowledgement should take
approximately 2 business days.
 Should the ceding application be used for NCI-cIRB
instead of the facilitated review applications? This will be
permitted within the next month. Continue to use
facilitated review applications until otherwise indicated.
Medical School
Institutional Review Board (IRBMED)
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Questions & Answers
If my central IRB is not on the list in the PAF or the IRB
application, how can it be added? Contact the IRBMED to
request consideration of the new IRB.
What central IRBs may be used at this time? Currently,
U-M has agreements with Chesapeake IRB and NCI. If you
would like to use a different central IRB, it requires
negotiation via our normal IRB review and ceding
procedures. As other central IRB agreements are finalized,
IRBMED will the notify the research community.
Medical School
Institutional Review Board (IRBMED)
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Questions & Answers
Why does U-M have an agreement with Chesapeake IRB?
Chesapeake IRB is accredited by the Association for the
Accreditation of Human Research Protection Programs
(AAHRPP) and has a strong FDA compliant track-record.
Is the process different when working with another
University/Institutional IRB? Yes, as UM is able to work
individually with other institutions to create IRB
Authorization Agreements through a less formal contractual
process.
Medical School
Institutional Review Board (IRBMED)
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Questions and Answers
Is there a fee associated with using a central IRB?
Independent IRBs will charge a fee which is usually paid by
the research sponsor. The process for payment will vary
depending on the Master Agreement with the independent
IRB. Work with your sponsor to determine how the fee will
be incorporated into your study budget.
University/Institutional IRBs may not charge a fee.
I am uncertain as to how to answer some of the questions
in the new eResearch ‘ceding’ application. Help text is
being written and will be posted as soon as it is available.
Medical School
Institutional Review Board (IRBMED)
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U-M Contacts
IRBMED 763-4768
Joe Austin (sjaustin@umich.edu)
Diana Miller (mildiana@umich.edu)
Georgia Marvin (gmarv@umich.edu)
Judy Birk (jbirk@umich.edu)
Consult with the IRBMED early in the application
process if you wish to use a Central IRB!
Medical School
Institutional Review Board (IRBMED)
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