Fda-ira

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):

________________________________________ Date: ___________

Print Full Name: ________________________________ Institutional Title: _____________________

NOTE: The IRB of Institution A must be designated on the OHRP-approved FWA for Institution B.

Signature of Signatory Official (Institution B):

________________________________________ Date: ___________

Print Full Name: ________________________________ Institutional Title: _____________________