Institutional Review Board/Independent Ethics Committee Registration Form

Institutional Review Board/Independent Ethics Committee Registration Form

0990-0279IRB-IEC Authorization Agreement January 08m

Institutional Review Board/Independent Ethics Committee Registration Form

OMB: 0990-0279

Document [docx]
Download: docx | pdf

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: _____________________



File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
File Modified0000-00-00
File Created0000-00-00

© 2024 OMB.report | Privacy Policy