HomeMy WebLinkAboutContract 46922 CL
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as � eview Board (IRB) Authorization Agreement
kame of ution or Organization Providing IRB Review(Institution/Organization A):
t6 f Texas Southwestern Medical Center
IRB Registration#: IORG0000638 Federalwide Assurance(FWA)#, if any: FWA00005087
Name of Institution Relying on the Designated IRB(Institution 8):
Federaiwide Assurance(FWA)#,if any: FWA00014800
The Officials signing below agree that University of Texas Southwestern Medical Center may rely on the
designated IRB for review and continuing oversight of its human subjects research described below: (check
one)
(_)This agreement applies to all human subjects research covered by Institution B's FWA.
LX_)This agreement is limited to the following specific protocol(s):
Name of Research Prosect: OUT-OF-HOSPITAL OBSERVATIONAL STUDY COMPARING AN AUTOMATED
EXTERNAL DEFIBRILLATOR(AED)ALGORITHM USING ICG AMPLITUDE VERSUS THE LAERDAL CPRMETER—TO
RETROSPECTIVELY CORRELATE RECORDED ICG AMPLITUDE TO Q-CPR DEPTH
Name of Principal Investigator:Ahamed Idris, M.D.
Sponsor or Fundina Amencv: HeartSine Technologies Ltd OFFICIAL RECORD
Award Number,if anv: N/A CITY SECRETARY
(_) Other(describe): �• WORTH,TX
The review performed by the designated IRB will meet the human subject protection requirements of
Institution B's OHRP-approved FWA. The IRB at Institution/Organization A will follow written procedures for
reporting its findings and actions to appropriate officials at Institution B. Relevant minutes of IRB meetings will
be made available to Institution B upon request. Institution B remains responsible for ensuring compliance
with the IRB's determinations and with the Terms of its OHRP-approved FWA. This document must be kept
on file by both parties and provided to OHRP upon request.
re of S ato Offi sal (Institution/Organization A):
i ' S Date'-1_/Lr-Zo iS--
Print Full Name:Angela Wishon,J.D. Institutional Title:VP for Research Administration
NOTE:The IRB of Institution A may need to i nated on the OHRP-approved FWA for Institution B.
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Signature o ignatory Official (Inst
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Print Full Name: v n itu ; Title: -Cl
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