A. Upload the following into IRBNet and submit the project package to the CORIHS Office.

Be sure to obtain signatures of PI and Chair, and 'share' your IRBNet project with all applicable individuals as you would if you were applying to CORIHS (e.g., William Greene, Wayne Patterson, Rhona Vainder and others as required. For details concerning use of IRBNet, please follow the directions available on our website:

  • 'External IRBs: Principal Investigator Certification' document: This outlines the requirements to which the PI must certify when s/he e-signs the IRBNet package. If the PI is not the individual creating the submission package, be sure the PI is made fully aware of the contents of this document before his or her e-signature is provided.  
  • SBU Application for Facilitated CORIHS Review of NCI Central IRB (CIRB) Approved Studies
  • Stony Brook University Hospital Facilities and Pharmacy Approval Form
  • Inclusion/exclusion criteria checklist: This checklist should contain required eligibility ranges where applicable, and a line to write the subject’s actual value. Completed and maintained for each subject, along with all backup documentation (lab values, x-ray reports, confirmation of diagnosis etc.), this information will provide definitive proof of your study subjects’ eligibility. 
  • CIRB application, protocol, notification letters, SAE reports and amendments, downloaded from the CIRB website
  • CIRB-approved consent form, modified in accordance with our local boilerplate language, HIPAA section, and contact information.

NOTE:

  • What you (and CORIHS) can’t do to the CIRB-approved consent form:
    • You cannot delete any information from the document.
  • What you (and CORIHS) can do to the CIRB-approved consent form:
    • You can make minor word substitutions or additions to the consent form, to conform to, e.g., our institution’s requirements or IRB policies, or to simply or clarify statements, as long as the changes do not alter the meaning of the CIRB-approved contents.
    • You can add additional risks as you deem necessary.
From www.ncicirb.org:
“…Revisions/changes to the local consent form other than those described above require full board review at the local level, facilitated review may not be used, and the CIRB cannot serve as the IRB of record for the protocol at the local site."
 

B. CORIHS staff will download the remaining CIRB documentation, i.e., CIRB reviews, minutes etc., relevant to the study being submitted locally for review.

C. Designated CORIHS member(s) will conduct a facilitated review of the downloaded documents.

There are three possible outcomes:
  • Approved (for CIRB Oversight): The CIRB will be designated as the IRB of record. You will receive an acceptance letter, a copy of the confirmation e-mail from the CIRB, and a hard copy of the local consent document(s).
  • Modifications Required (in order to secure approval for CIRB Oversight): Specific stipulations must be addressed before the CIRB can be designated as the IRB of record. See consent form issue above, and:

    From www.ncicirb.org: “…the local IRB may add stipulations or local requirements to protocols, particularly to increase subjects' safety, to clarify procedures, etc., but may not delete or contradict any protocol contents…”

  • Protocol Not Accepted (for CIRB Oversight): Local IRB oversight is required. You must complete a local IRB application and submit materials to the IRB office via the standard application process. The CIRB will not be permitted to oversee the protocol.
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