Multicenter Studies: Required Documents for IRB Review

• What is a definition of a multi-center study?
• Engaging in research with institutions with whom FHCRC has a Cooperative Review Agreement
• For performance sites where FHCRC does not have a Cooperative Review Agreement.  What are the three (3) types of documentation that may be used by the FHCRC IRB?

• IRB Certification of Approval for performance sites
• IRB Authorization Agreement
• Individual Investigator Agreement

What is a definition of a multi-center study?

It is a study involving more than one performance site engaged in research with Fred Hutchinson Cancer Research Center (FHCRC).

Engaging in research with institutions with whom FHCRC has a Cooperative Review Agreement

Currently, FHCRC has cooperative review agreements with the IRBs of the following institutions:

• University of Washington
• Seattle Children's
• Seattle Cancer Care Alliance (SCCA)
• Group Health Cooperative
• Benaroya Research Institute at Virginia Mason
• Washington State Department of Health involving cancer registry studies. 

Typically these institutions will accept FHCRC IRB review and vice versa.  If you are uncertain which institution's IRB should be the IRB of record, contact the IRO. 

Seattle Children's relies on FHCRC as the IRB of record for transplant related protocols.  However,  there are certain cases where it may make more sense to allow Seattle Children's to be the IRB of record.  If you meet one of the following criteria, please contact the IRO to discuss the study and who should be the IRB of record before filling out the IRB forms.

• Both FHCRC and Seattle Children's hold funding for the project
• The study is not clearly transplant related and you will be conducting procedures at Seattle Children's.

If you plan to conduct research with performance sites not listed above, you may be required to provide additional documentation to the FHCRC IRB (see next section below).
For more specific information regarding Cooperative Review Agreements, click here.  

For performance sites where FHCRC does not have a Cooperative Review Agreement.  What are the three (3) types of documentation that may be used by the FHCRC IRB?

There are three (3) types of IRB documents (see next section below) that may be used when a FHCRC investigator engages in research* with a collaborating investigator or performance site with which FHCRC does not have a Cooperative Review Agreement.  These documents provide documentation of appropriate IRB oversight of FHCRC multi-site study at performance site and/or collaborating investigator engaged in research in accordance with Federal Policy 45CFR46.103.

*The Office of Human Research Protections (OHRP) defines "engaged in research" when its employees or agents (1) intervene or interact with living individuals for research purposes; or (2) obtain, receive, or possess individually identifiable private information for research purposes.

Note:  If you are conducting a Clinical Research Division (CRD) or Cancer Consortium protocol, please refer to the Clinical Research Support Multicenter Guidelines. 

The three (3) types of documentation are: 

1.  IRB Certification of Approval for performance sites

The IRB Certification of Approval for performance site is also called Assurance Identification/IRB Certification/Declaration of Exemption (formerly called Optional Form 310)
This form is used when:

• FHCRC engages in research with a performance site
• FHCRC is the "coordinating center"
• A performance site has an approved Federalwide Assurance (FWA) with the Office of Human Research Protections (OHRP)
• A performance site conducts its own IRB review of the study/protocol 

[form and instructions]

2.  IRB Authorization Agreement Form 

This form is used when:

• FHCRC engages in research with a performance site who may or may not rely on FHCRC's IRB review in order to avoid the need for dual review
• A performance site must have an approved Federalwide Assurance (FWA) with OHRP
• The two IRB offices (FHCRC and the performance site) determine who will be the IRB of record

[forms and instructions]

3.  Individual Investigator Agreement Form

This form is used when:

• FHCRC engages in research with an individual (not a site) at a non-FHCRC affiliated site
• The individual is affiliated with a site that does not have its own IRB (e.g. clinic or a small community hospital)
• The individual fulfills the FHCRC's human subjects training requirements for non-FHCRC  investigators prior to initiating research covered under this agreement. 

[form and instructions]