BRANY Central IRB for NCI

BRANY IRB has extended the contract with National Cancer Institute (NCI) to serve as a Central IRB to review Virtual Pooled Registry – Cancer Linkage System (VPR–CLS) studies as well as studies utilizing data from the SEER Tier 4 databases.

The Common Rule requires use of a Central (or single) IRB for cooperative research.  Reliance on a Central IRB can eliminate redundancy and provide a consistent, high quality, expert review process that protects privacy and confidentiality while saving time and resources.

Here is an outline of the process to receive provisional approval from SEER through the SEER Specialized Database Request System

  • IRB Review – NCI SEER requires review by NCI/DCCPS central IRB (cIRB) – currently BRANY IRB
    • If you have a local IRB, obtain approval or determination from local IRB first
    • If your institutional IRB has executed a reliance agreement with BRANY IRB, you do not need your institutional IRB review prior to applying for cIRB review.
    • If your institution or company does not have a local IRB, you can proceed with your cIRB application at this point.
  • Submission to BRANY IRB via IRBManager online portal
    • Obtain a user account
    • Log into IRBManager and complete the OBTAIN BRANY ID# xForm (electronic form)
      • Attach:
        • Protocol (study plan) – Click here for a template: Protocol Template
        • List of data variables requested
        • Copy of NCI Provisional Approval PDF
        • Copy of submission to and determination from your local IRB, if applicable.
      • Answer basic questions about the nature of your research activity.
      • Identify the Principal Investigator (PI) and any others that may need access to this study record in the BRANY IRBManager portal.
    • The project will be assigned a BRANY ID#. You will receive an email with your study ID # and further instructions in the event additional application materials are needed
  • Upload cIRB Letter to SEER Specialized Data Request System

 

 

 

  • Request for User Access - After you receive your initial approval, and would like access to IRBManager, please send a completed Request for User Access Form by email to Laura Donohue (or call 516-622-2049)
  • IRBManager™ Demonstration Webinar
    • Check the box to request a demonstration on the Request for User Access form
    • Email rhart@brany.com

Reporting Timelines

UPIRTSOS (Unanticipated Problems) Report per occurrence within 5 days
Serious Adverse Events (Local) Report per occurrence within 5 days
Unanticipated Adverse Device Events (UADEs) Report per occurrence within 10 days
Complaints Report per occurrence within 5 days
Major Deviations Report per occurrence within 10 days
Minor Deviations Report in aggregate with continuing review or study closure