Assurance Identification/IRB Certification/Declaration of Exemption (formerly called Optional Form 310)

• When is the Assurance Identification/IRB Certification/Declaration of Exemption used?
• Submission Instructions

When is an Assurance Identification/IRB Certification/Declaration of Exemption Form 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 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 Federal Wide 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

  For New Studies:

  A Performance site with an approved and current Federal Wide Assurance (FWA) on file with OHRP can submit IRB approval documents in one of three ways:

  1. The approval documents 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
     • Principal Investigator's name
     • Performance site's FWA #
     • Review Date and approval dates
     • Type of Review: Full or Expedited
     • The current consent form(s) must be included
  2. A memo on the performance site's letterhead which includes the following information (e.g. protocol number, title of protocol, etc) as requested above in Item 1.
  3. An Assurance Identification/IRB Certification/Declaration of Exemption (formerly called Optional Form 310) can be completed by the performance site's IRB and submitted along with a copy of the most current consent form(s).
     • Blank Assurance Identification/IRB Certification/Declaration of Exemption Form

  For Ongoing Studies

  • The FHCRC PI submits a completed Protocol Modification Form (PMF) 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).
  • Follow the submission instructions above for New Studies

  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.

  The IRO is also responsible for sending out Continuation Review notices at least annually to the collaborating performance sites to assure that IRB continuation review has been conducted in compliance with relevant regulations.