Multicenter Studies: Required Documents for IRB Review

There are three (3) types of IRB documents that are required when a FHCRC investigator engages in research* with an investigator or participating site with whom FHCRC does not have a cooperative review arrangement. Currently, FHCRC has cooperative review agreements with the IRBs of the following institutions: University of Washington, Swedish Medical Center, Children's Hospital and Regional Medical Center, Group Health Cooperative, Benaroya Research Institute at Virgina Mason, and Washington State Department of Health involving cancer registry studies. These documents provide documentation of appropriate IRB oversight of FHCRC multi-site study at partipating site and/or independent 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 Research Trials Office (RTO) Multicenter Guidelines. 

The three (3) types of documentation are:

1. Assurance Identification/IRB Certification/Declaration of Exemption
   (formerly called Optional Form 310)
   [form and instructions]
   
   This form is used when:
   • FHCRC engages in research with participating sites
   • FHCRC is the "coordinating center"
   • The participating site must all have an approved Federal Wide Assurance (FWA) with the Office of Human Research Protections (OHRP)
   • The participating site conducts its own IRB review of the study/protocol

2. IRB Authorization Agreement Form
   [form and instructions]
   
   This form is used when:
   • FHCRC engages in research with a participating site who may or may not rely on FHCRC's IRB review inorder to avoid dual review
   • The participating site must have a FWA
   • The two IRB offices determine who will be the IRB of record

3. Individual Investigator Agreement Form
   [form and instructions]
   
   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 must fulfill the FHCRC human subjects training requirements for non-FHCRC investigators prior to initiating research covered under this agreement.