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 created by Office for Human Research Protections (OHRP)
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