Application for IRB Authorization Agreement

Relevant IRB policies/procedures:

  • IRB Authorization Agreement (Policy 2.24)  [pdf]
  • Multi-Center Study Coordination (Policy 2.14)  [pdf]
  • Continuing Review (Policy 2.2)  [pdf]
  • Closure and Re-open (Policy 2.9)  [pdf]
  • Federalwide Assurance (Policy 1.2)  [pdf]

[all IRB policies]

 

    

When is an IRB Authorization Agreement used?

This agreement is used when FHCRC engages in research with:

A performance site with whom FHCRC currently does not have a Cooperative Review Agreement and

Only one institution's IRB will review the study to avoid the need for dual review - Either FHCRC or the performance site. 

    

Requirements

If an IAA is appropriate for your research study, please contact the IRO Director, Karen Hansen at (206) 667-4867 or the IRO Assistant Director, James Riddle at (206) 667-6501 to determine which institution (FHCRC or the performance site) will be the IRB of Record.

IRB Authorization Agreement Designation:

Institution A = In most cases, the Institution conducting the IRB review is the site where participant accrual takes place.

Institution B = The Institution who relies on the other Institution's IRB review.

In order for the IAA to be processed and approved, the performance site must have an approved Federalwide Assurance (FWA) on file with the Office of Human Research Protections (OHRP).  If the performance site does not have a FWA, the performance site must first apply for a FWA.  Instructions for applying for a FWA through OHRP are found at http://www.hhs.gov/ohrp/assurances/assurances/file/index.html.  In addition to the performance site having an approved FWA on file with OHRP, the performance site's IRB registration must also be current with OHRP. 

   

General Submission Instructions

The IRB requires ONLY the ORIGINAL DOCUMENTS for processing your IRB application. All documents must be single-sided. Please do not use staples. It is recommended that a complete set of the documents submitted to the IRB be kept for your records.  Submit the documents to J2-100.   

Submission Instructions when FHCRC is the IRB of Record

    

                Submission Instructions for New Studies

                  • Complete the appropriate Application for Review (Invertentional, Observational, or Human Specimen or Data Research)

                    The application must include a description of the performance site's engagement with the research study.

                Include the performance site in need of the IAA indicating FHCRC as the IRB of record and all necessary site documentation as outlined on the supplement form (e.g. site PI Human Subject's training, CV, license).

                The FHCRC Principal Investigator (PI) is responsible to complete the IAA and obtain signature of the institutional official at the performance site.  The IAA must include the delineation of duties attachment.  Once approved the FHCRC IRB, the IRO Director will sign the FHCRC side of the IAA.

                    

                Submission Instructions for On-Going Studies

                  •  Research Modification Form (RMF)   [download word doc]
                    • For "Reason for Modification, describe the performance site's engagement with the research study
                    • Revise any documents (e.g. consent forms, protocol) if appropriate.  Use the "track changes" feature to identify changes on one copy, and include a "clean copy" of the document(s).

                Submit an updated or new supplement reflecting the new performance site indicating FHCRC as the IRB of record and all necessary site documentation as outlined on the supplement form (e.g. site PI Human Subject's training, CV, license).

                The FHCRC Principal Investigator (PI) is responsible to complete the IAA and obtain signature of the institutional official at the performance site.  The IAA must include the delineation of duties attachment.  Once approved the FHCRC IRB, the IRO Director will sign the FHCRC side of the IAA.

                    

                After the IAA is Signed by Both FHCRC and the Performance Site

                • The IRO will forward copies of the signed IRB Authorization Agreement to the performance site's and FHCRC's contact persons.

                    

                Submission Instructions When FHCRC is Relying on the Performance Site's IRB for Review

                Submission Instructions

                  • Application for Review - New Cooperative Review IRB Auth Agreement Cover Sheet  [download word doc]

                    Contact the IRO Director before initiating communication with the performance site to ensure FHCRC will rely on the outside institution.
                  • Approval documents from the performance site
                      • The submission packet must include the complete copy of the approval documents from the performance site with the current signatures and dates of approval, including the most current version of the:
                        • Protocol, if applicable
                        • Informed Consent documents, if applicable
                        • All participant materials, e.g. questionnaires, advertisements, etc.
                      • If the study has been on-going, the submission packet must also include any continuation review/status reports from the beginning of the study.
                      • The approval documentation from the performance sites' IRB must clearly show their approval of the FHCRC site and our institution's role in the project. 

                  The FHCRC Principal Investigator (PI) is responsible to complete the IAA and obtain signature of the institutional official at the performance site.  The IAA must include the delineation of duties attachment.  Once approved the FHCRC IRB, the IRO Director will sign the FHCRC side of the IAA.

                      

                  Additional Considerations

                    • Please note that this application may receive expedited review by the IRB Chair.  If the IRB Chair determines that full review is required, the IRB will notify the PI and contact person.
                    • Once the IAA is signed by both the FHCRC and performance site, the IRO will forward copies of the signed IAA to the performance site and to the FHCRC contact person.

                      

                  Approval Period and Continuing Review Requirements

                  When FHCRC is relying on the performance site for IRB review, the approval period is the same as the performance site's approval period and the FHCRC PI is responsible to submit Continuing Review Reports to the IRO with copies of the performance site's IRB approval documents.

                  The IRO is responsible for sending out Continuation Review Renewal Notices at least once a year (or more often if appropriate) to the FHCRC PI/contact person assure that IRB continuing review has been conducted in compliance with applicable regulations.

                  [Instructions for Continuation Review Requirements for IAA]

                      

                  Terminating IRB Authorization Agreements

                  [Instructions for Terminating IAAs]

                   

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