National Cancer Institute’s Central IRB Adult and Pediatrics Initiative (CIRB) Submission Guidelines

Stony Brook University participates in the National Cancer Institute’s Central IRB Adult and Pediatrics Initiative. All participation in research activity reviewed under NCI-CIRB must first be approved by the Cancer Center Protocol Review Committee (PRMC). Once approval by the PRMC committee has been granted, complete the NCI-CIRB investigator worksheet on the NCI-CIRB Website.

Overview

This Quickguide outlines the process of how a study is reviewed, including central review of the study and local context review.

 

When NCI-CIRB has approved the research and local site investigator, submit the study in myResearch for local administrative review. The submission package must include all the required documentation outlined in the submission guidelines in addition to:

• Main site approval letter
• Local Investigator Approval Letter
• Template version, track changed and clean final copies of the Informed Consent Form.
  • NCI-CIRB has specific guidelines for any word alterations/substitutions to the informed consent document. Please review the permitted boilerplate language
• Final HIPAA Authorization Form (track changed and clean copies)

NOTE:

• The translation of the informed consent form is the responsibility of the local institution.

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."

 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…”