Multicenter Studies: Review Requirements

Relevant IRB policies/procedures:

  • Multi-Center Study Coordination - IRB Review and Oversight (Policy 2.14) [pdf]
  • Cooperative Review Agreements (Policy 2.3) [pdf]
  • IRB Authorization Agreement (Policy 2.24) [pdf]
  • Federalwide Assurance (Policy 1.2) [pdf

[all IRB policies/procedures]

    

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).

*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. 

    

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:

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 other performance sites desiring to rely on FHCRC IRB review

There are two types of IRB documents that may be used when a FHCRC investigator collaborates with performance site who desires to rely on FHCRC IRB as the IRB of Record and 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.    

1.  IRB Authorization Agreement Form    

This form is used when: FHCRC engages in research with a performance site that has an approved Federalwide Assurance (FWA) who would like to rely on FHCRC's IRB review in order to avoid the need for dual review.  The performance site must agree to the delineation of responsibilities outlined in the authorization agreement form.  The FHCRC PI provides the following as part of the Multi-Center Supplement form:

[form and additional instructions]

 2.  Individual Investigator Agreement Form

This form is used when: An FHCRC PI collaborates with an individual investigator at a performance site that does not have an approved FWA(e.g. clinic or a small community hospital).  Under this agreement the individual investigator is covered under the FHCRC FWA and must agree to follow the Center's Human Research Protection Program requirements.  The FHCRC PI provides the following as part of the Multi-Center Supplement form:

  • Description of research activity to be conducted at the performance site
  • Name, Credentials, CV, and Training of the Individual Investigator
  • Confirmation of Individual Investigator's training in human subject protection
  • Description of the adequacy of the performance site to conduct research activities
  • For performance sites conducting clinical procedures, a copy of the Individual Investigator's medical license and proof of Good Clinical Practice training
  • Letter of support from the Individual Investigator's institution

[forms and additional instructions]

     

If you have questions regarding any of these IRB required documentation for multi-site studies, please contact James Riddle at (206) 667-6501.

 

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