Institutional Review Board (IRB) Authorization Agreement
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).
Institution or Organization Providing IRB Review:
Name (Institution/Organization A): __________
IRB Registration #: __________
Federalwide Assurance(FWA)#, if any: __________
Institution Relying on the Designated IRB (Institution B):
Name: __________
FWA#: __________
The Officials signing below agree that __________(name of Institution B) 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.
(___) 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: __________
Content last reviewed on July 31, 2017