Application for IRB Authorization Agreement

Relevant IRB policies/procedures:

• IRB Authorization Agreement (Policy 2.24) [pdf]

[all IRB policies / procedures]

• When is an IRB Authorization Agreement used?
• Requirements
• Submission Instructions

When is an IRB Authorization Agreement used?

This form is used when FHCRC engages in research with:

1. An organization/institution with whom FHCRC currently does not have a cooperative review arrangement, and
2. Either FHCRC or the collaborating organization/institution provides IRB (human subject) review to avoid dual review

Requirements

IRB Authorization Agreement designation:

1. Institution A: In most cases, Institution A (the institution conducting the IRB review) is the site where participant accrual takes place.
2. Institution B: The institution who relies on Institution A's IRB review

In order for the IAA to be processed and approved, the offsite institution must have an approved Federal Wide Assurance (FWA) on file with the office for Human Research Protections (OHRP). If the offsite institution does not have a FWA or any other type of assurance, the institution must first apply for a FWA. Instructions for applying for an FWA through OHRP are found http://www.hhs.gov/ohrp/assurances/assurances_index.html. If you have questions about filing, please contact the Institutional Review Office at (206) 667-5900.  In addition to the offsite institution having an approved FWA on file with OHRP, the offiste institution's IRB registration must be current with OHRP.

Submission Instructions

1. For New Studies: If an IRB file does not currently exist, the FHCRC PI must submit the appropriate IRB application form which includes a description of the offsite institution's engagement in the research activity. Also submit a Protocol Disposition Form (Word doc):
   • For "Type of Review Requested", please check "IRB Authorization Agreement"
   • Provide the name of the Offsite Principal Investigator's Name
   • Provide Review Location (FHCRC)
   • Provide the Offsite's FWA number
2. For Ongoing Studies, the FHCRC PI will complete a Protocol Modfication Form (PMF) adding the offsite institution to the study. The PMF should also include a description of the offsite institution's engagement in the research activity. Revise any documents (e.g. consent forms, protocols), if appropriate. Use the "track changes" feature to identify changes on one copy, and include a "clean copy" of the document(s).
   • Protocol Modification Form (Word, 51KB)
3. The FHCRC PI will complete the IAA and obtains the signature of the Offsite Institution's signatory official.
   • IRB Authorization Agreement Form for Institution A.  (Word, 35.5KB)
4. The FHCRC PI will submit the signed IAA along with the completed PMF and other documents, if appropriate for final review and approval.
5. It is the responsibility of the offsite institution to add FHCRC to their Federal Wide Assurance (FWA) with OHRP, designating FHCRC as the IRB of Record.
6. Once the application receives final approval, the IRO will forward one copy of the approved documents to the Contact Person.

When FHCRC is Institution B and relies on the Offsite Institution's IRB for review

1. The FHCRC Principal Investigator (PI) completes the Protocol Disposition Form.
   • Page 1, Protocol Disposition Form (Word, 51KB)
   • For "Type of Review Requested", please check "IRB Authorization Agreement"
   • Provide the name of the Offsite Principal Investigator's Name
   • Provide Review Location (Name of Offsite Institution - "Institution A")
   • Provide the Offsite's FWA number
2. The FHCRC PI will collect the offsite institution's initial approved application (protocol, consents and other relevant documents, if applicable). If the study is ongoing, copies of currently approved renewal document(s) must also be collected. If required, the IRB will assist the Offsite PI to provide the required IRB approved documents.
3. The offsite documents must include a description of FHCRC engagement in the research study.
4. The FHCRC PI will complete the IAA and obtains the signature of the offsite institution's signatory official.
   • IRB Authorization Agreement Form when FHCRC is Institution B.  (Word, 35.5KB)
5. The FHCRC PI will submit the complete packet of documents including the signed IAA to the IRB for review and approval. The packet of documents at a minimum, will include the currently approved consent(s), protocol, original application form. It should also include the funding source document which describes FHCRC's engagement in this research activity.
6. Please note that this application may receive expedited review by the IRB Chairperson. If the IRB Chairperson determines that full review is required, the IRB will notify the PI and contact person.
7. Once the application receives final approval, the IRO will forward one copy of the approved documents to the Contact Person.

The IRO is responsible for sending out Continuation Review notices annually (or more often if appropriate) to the offsite institutions to assure that IRB continuation review has been conducted in compliance with relevant regulations.