Stony Brook University Office of Research Services

Contact

NCI CIRB
1-888-657-3711
Reginald Johnson
rjohnson@ctisinc.com

Judy Matuk, Assistant VP for Research Compliance
W5530 Melville Library
Stony Brook, NY 11794-3368
Tel: (631) 632-9036
Fax: (631) 632-9839
judy.matuk@stonybrook.edu

Useful Websites

NCI's Central IRB Adult and Pediatrics Initiative

Stony Brook University is a participant in the National Cancer Institute’s Central Institutional Review Board (CIRB) Initiative. Local investigators who wish to enroll patients onto CIRB-approved protocols are encouraged to utilize this service. Such investigators should first contact Ms. Judy Matuk so that she may complete paperwork to secure a username and password for the PI and study coordinator NCI requires that investigators wishing to do so must first submit CIRB review materials (along with minimal local paperwork) to their local IRB (CORIHS) for a facilitated review (similar to our expedited review process), to confirm the acceptability of CIRB as the IRB of record for that particular study.

Instructions for Use of NCI CIRB

  1. 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:
    • SBU Application for Facilitated CORIHS Review of NCI Central IRB (CIRB) Approved Studies
    • Stony Brook University Hospital Facilities and Pharmacy Approval Form
    • 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 don’t 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."
  2. CORIHS staff will download the remaining CIRB documentation, i.e., CIRB reviews, minutes etc., relevant to the study being submitted locally for review.
  3. Designated CORIHS member(s) will conduct a facilitated review of the downloaded documents. There are three possible outcomes:
    1. 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).
    2. 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…”

    3. 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.

When your Protocol has been Approved for CIRB Oversight

Once the CIRB is designated as the IRB of record for your study, your interaction with CORIHS will be minimal, but very important.

  • Consent Form Revisions: The CIRB will notify the PI and coordinator (by e-mail) when changes to the consent have been made and posted on the CIRB website. Make all changes on the local consent, update the header to match the CIRB approved consent and submit one copy to CORIHS for our records. No approval letter will be issued by CORIHS.
  • Continuing Reviews: Continuing review will be conducted by the CIRB. The PI and the coordinator will receive e-mail notification of these reviews from CIRB. Submit one copy of CIRB’s review for the study, the updated local consent form, and SBU’s Continuing Review Application for NCI CIRB Studies. No approval letter will be issued by CORIHS.
  • Unanticipated Problems (including Serious Adverse Events (SAEs): You must submit all Unanticipated Problems occurring in subjects enrolled through SBU (“local UP’s”) to CORIHS, in accordance with CORIHS policy at: http://www.research.sunysb.edu/HSG/HSGsec16.html#16.E
    From www.ncicirb.org:
    “Your local IRB is still responsible for reviewing SAE's that occur at your site; for all others, the CIRB does the review. Investigators continue using their routine reporting procedures. There is no need for the investigator to report SAE's to the CIRB. SAE's are reported using the customary mechanisms on CTEP-sponsored phase III protocols (Cooperative Group and others); the CIRB will be able to access SAE reports directly from NCI, to review SAEs and to report back to participating local IRBs via a confidential web site.”
  • Local Alterations (e.g., Personnel, Advertisements etc.) Submit any local personnel changes, local advertisements etc. to CORIHS for review and approval. Notification from CORIHS regarding review outcome (approval, modifications required etc) will be sent to you.
  • Study Closure: To close a CIRB study at this site, submit a “Termination Request Form” to the CORIHS, who will, in turn, notify the CIRB.
  • Protocol Amendments (NOT TO BE SENT TO CORIHS): Whenever the Cooperative Group makes protocol amendments; you must use only the CIRB approved version. These can be downloaded from the CIRB website through the investigator log-in access.