Sample:  IRB Authorization Agreement

 

Sample text for an Institution with a Federal wide Assurance (FWA) to rely on an IRB outside their institution (institutions may use this sample as a guide to develop their own agreement).

 

IRB Authorization Agreement

 

Name of Institution or Organization Providing IRB Review (Institution A):

______________________________________________________________________

 

IRB Registration #: __________ Federal wide Assurance (FWA) #, if any: ___________

 

Name of Institution Relying on the Designated IRB (Institution B):

________________________________________________________________________    

 

OHRP Federal wide Assurance (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 subject research described below:  (check one)

 

(___) This agreement applies to all human subject 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 and continuing oversight performed by the designated IRB will meet the human subjects protection requirements of Institution B’s OHRP-approved FWA.  The IRB at Institution 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 Assurance.  This document must be kept on file at both institutions and provided to OHRP upon request.

 

Signature of Signatory Official (Institution A): _____________________ Date: _______

 

Print Full Name:  _____________________ Institutional Title: _____________________

 

Signature of Signatory Official (Institution B): ___________________ Date: ________

 

Print Full Name:  _____________________ Institutional Title: _____________________

 

Form is available at: http://ohrp.osophs.dhhs.gov/humansubjects/assurance/iprotsup.rtf

 

Obtain the correct forms (see Researcher's handbook for information about forms) from the UND IRB Web Site (http://www.und.edu/dept/orpd/