Research > NCI CIRB Submissions

NCI CIRB Submissions

The LBH IRB acknowledges the National Cancer Institute (NCI) Central Institutional Review Board (CIRB). Any study that has been reviewed by the NCI CIRB must be submitted to the LBH IRB for review. The LBH IRB requires the following:

New Studies:  

  • Current CIRB Approval Letter
  • LBH Assent and Consent Forms
  • Protocol
  • Investigator Brochure and/or package insert(s) (drugs and biologics)
  • Report of Prior Investigation or FDA Summary Data of Safety and Effectiveness and Device Classification information (devices) if available
  • Investigator Delegation of Responsibility Form
  • Miscellaneous Information (advertisements, patient letters, etc.)

Continuing Renewals:

  • Waiver for Disclosure for use of PHI in a Research Study 
  • Continuing Review of a Study Ceded to An External IRB Form
  • CIRB Continuing Renewal Approval Letter 
  • Current approved LBH Assent and Consent Forms (no model or tracked changes required)
  • Protocol
  • Investigator Delegation of Responsibility Form
  • Investigator Brochure and/or package insert(s) (drugs and biologics (if available)
  • Report of Prior Investigation or FDA Summary Data of Safety and Effectiveness and Device Classification Information (Devices) (if available)
  • Miscellaneous Information (advertisements, patient letters, etc.) (as applicable)
  • Significant Internet and Disclosure Questionnaire 

Revisions/Amendments:

  • CIRB Approval Letter
  • Summary of Changes
  • LBH Assent and Consent Forms (no model or tracked changes required)
  • Protocol
  • Action Letters (if applicable)
  • Investigator Brochure (if applicable)
  • Miscellaneous Documents (if applicable)
  • Waiver for Disclosure for use of PHI in a Research Study

Local Adverse Events:

Both the CIRB adverse event reporting requirements and the LBH IRB Unanticipated Problem/Adverse Event Report Form must be adhered to.  The LBH IRB also requires a copy of the CIRB determination.