OHRP – FWA Sample Text
Version Date: 12/20/2005
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)/Independent Ethics Committee (IEC) 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 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):
Print Full Name:________________________________
NOTE: The IRB of Institution A must be designated on the OHRP-approved FWA for Institution B.
Signature of Signatory Official (Institution B):_______________________
Print Full Name:____________________________________
Institutional Title: _______________________________