What Are SBU Responsibilities Re: CRRI-Reviewed Protocols

SBU/Office of Research Compliance Responsibilities Prior to Protocol Submission to CRRI

The IRBNet package will be reviewed/assessed as follows:

  • Eligibility to use CRRI
  • Completion/submission of all required documents
  • Office of Sponsored Programs receipt and approval of associated COEUS proposal
  • Current CITI training for all personnel listed in the registration form
  • Current financial disclosure documents for PI and all personnel listed on the registration form, and where there is a financial COI, a signed management plan through the COI committee (for forwarding to CRRI IRB)
  • E-signatures of PI and Chair
  • E-signatures for all personnel listed in the registration form, certifying that they:
    • are fully cognizant of the details of the protocol, and will conduct all aspects of the study as approved by CRRI
    • will promptly report to the PI any unanticipated problems or serious adverse events affecting risk to subjects or others, and
    • will not be involved in any aspect of the study for which they have not been trained, or conduct any procedure in which they are not certified/licensed

Once all of the above are satisfied, the PI will be sent an e-mail asking for confirmation that the study will not be initiated until CRRI IRB approval is granted, the sponsor-RF contract is fully executed, and Dr. Laver (for device studies only) and all other applicable UH administrators have e-signed the IRBNet package for the study. When the confirmation is received, CRRI will be notified to commence review of the submitted protocol. Concurrent with this notification may be reminders of special considerations for local context, FCOI, and SBU-specific SOPs that must be considered during IRB review.

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