IRB Authorization Agreement Sample

IRB Authorization Agreement.pdf

Federalwide Assurance (FWA)

IRB Authorization Agreement Sample

OMB: 0990-0278

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Version Date: 02/28/2020

Sample text for an Institution with a Federalwide Assurance (FWA) to rely on the IRB/IEC of another institution
(institutions may use this sample as a guide to develop their own agreement).

Institutional Review Board (IRB) Authorization Agreement
Name of Institution or Organization Providing IRB Review (Institution/Organization A):
___________________________________________________________________________________
IRB Registration #: ________________ Federalwide Assurance (FWA) #, if any: _________________

Name of Institution Relying on the Designated IRB (Institution B):
___________________________________________________________________________________
FWA #: _____________________
The Officials signing below agree that
(name of Institution B) may rely on the designated IRB f or
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.
(___) This agreement is limited to the following specific protocol(s):
Name of Research Project:________________________________________________________
Name of Principal Investigator:_____________________________________________________
Sponsor or Funding Agency: ________________ Award Number, if any: _________ __________
(___) Other (describe):________________________________________________________________
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.
Signature of Signatory Official (Institution/Organization A):
________________________________________ Date: ___________
Print Full Name: ________________________________ Institutional Title: _____________________

Signature of Signatory Official (Institution B):
________________________________________ Date: ___________
Print Full Name: ________________________________ Institutional Title: _____________________


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File Modified2023-04-12
File Created2023-04-12

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