IRB Certification of Approval - THIS PROCESS HAS BEEN RETIRED, NO LONGER REQUIRED, AS OF 5-15-2014

Relevant IRB policies/procedures:

  • Multi-Center Study Coordination - IRB Review and Oversight (Policy 2.14) [pdf]
  • Closure and Re-open (Policy 2.9) [pdf]

[all policies and procedures]

    

What is an IRB Certification of Approval?

An IRB Certification of Approval is one of three types of IRB documents that may be used when an investigator engages in research with a collaborating performance site with which FHCRC does not have a Cooperative Review Agreement.  The other two types of IRB documentation are 1) IRB Authorization Agreement and 2) Individual Investigator Agreement.

    

When is an IRB Certification of Approval used?

  • An IRB Certification of Approval is used when FHCRC acts as the "coordinating center" of a multi-center study, the FHCRC IRO is responsible for obtaining and maintaining IRB (human subjects) approval documents from each performance site. The Office of Human Research Protections (OHRP) defines a performance site as a site whose staff, facilities or private records of identifiable individuals are utilized in the conduct of research. Solicitation of consent by site staff would be considered engagement or receives Federal funds. As the coordinating center, FHCRC is ultimately responsible for protecting human subjects for the study.
  • Each performance site must have an approved Federalwide Assurance (FWA) on file with the Office of Human Research Protections (OHRP)
  • The IRB (human subjects committee) of each performance site reviews and approves the research activity before accrual of research participants can began at that site. 

    

Submission Instructions

Submission Instructions for New Studies:

Along with the New Application for Review, the FHCRC PI submits:

  •  Multi-Center Supplement [download Word doc]
  • The approval document from the performance site.  The approval document can be submitted in one of two ways:
        1. An Assurance Identification/IRB Certification/Declaration of Exemption (formerly called Optional Form 310) can be completed by the performance site's IRB;
        2. The approval document from the performance site's human subjects (IRB) office which includes the following:
          • Protocol number or institution's identification number (e.g. IRB number)
          • Title of the protocol
          • Offsite Principal Investigator's name
          • Performance site's FWA and IRB #s
          • Review Date and approval dates
          • Type of Review (e.g., Full or Expedited)

    

Submission Instructions for Ongoing Studies:

The FHCRC PI submits:

    •  A completed Research Modification Form (RMF) adding the new performance site to the study. The PMF should also include a description of the performance site'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).
    • A revised Multi-Center Supplement [download Word doc]
    • The approval document from the performance site.  The approval document can be submitted in one of two ways:

1.  An Assurance Identification/IRB Certification/Declaration of Exemption (formerly called Optional Form 310) can be completed by the performance site's IRB;

Blank Assurance Identification/IRB Certification/Declaration of Exemption Form

2.  The approval document from the performance site's human subjects (IRB) office which includes the following:

          1. Protocol number or institution's identification number (e.g. IRB number)
          • Title of the protocol
          • Offsite Principal Investigator's name
          • Performance site's FWA and IRB #s
          • Review Date and approval dates
          • Type of Review (e.g., Full or Expedited)

    

When the performance site does not have an approved Federalwide Assurance (FWA)

If the performance site does not have an approved FWA on file with OHRP, an Assurance must be approved with OHRP before the research can began at the performance site. Instructions for applying for an FWA through OHRP are found online. If you have questions about filing, please contact the Institutional Review Office at (206) 667-5900 or llodzins@fhcrc.org.

    

Continuing Review Requirements

[See Continuation Review Report for more detailed instructions]

    

What documents do I need to submit to the FHCRC IRB when a performance site's engagement ends?

Submit any documentation (email, letter, memo) stating that the performance site no longer engaged in research with FHCRC.

 

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