IRB registration

IRB registration

Investigator IRBNet registration and use requirements

Purpose: to provide direction on IRBNet registration and use

Scope: Applies to all investigators who will be conducting any type of research or academic quality improvement (QI) projects

Responsibilities: All investigators will register for IRBNet prior to starting any research or academic QI project and will use the system as required

Background: IRBNet was developed in 2001 under the National Institutes of Health program for Human Subjects Research Enhancement Awards. IRBNet provides a secure, reliable, easy-to­use and affordable solution to research institutions of all sizes and all types and is accessible to the research community anytime, anywhere. IRBNet’s suite of electronic solutions drives compliance and productivity for your Administrators, Committee Members, Researchers and Sponsors. Primary benefits are to streamline your submission and review processes, reduce paper, packets and mailings, cut time, increase process transparency, maintain a clear audit trail, and to share information seamlessly and securely in real time. Under CFR 21, Part 11, Section 11.10 IRBNet affirms that the IRBNet system is fully compliant with the technology requirements for Electronic Records. Further system functions are found on the IRBNet.org website.

Procedure

Registration: 

  1. Investigator can obtain direction from
    1. CU IRB Education and Training site
    2. CU Clinical Research Office (Research - ResearchAcademic [at] creighton [dot] edu, QI - QIAcademic [at] creighton [dot] edu)
  2. Investigator must register with IRBNet at www.IRBNet.org
  3. IRBNet registration instructions can be found at https://www.creighton.edu/researchservices/rcocommittees/irb/infoed/subm…
  4. Use an email address that is regularly used by investigator
  5. Affiliate with Creighton University. Enter Creighton email address

Use:

  1. Clinical Research Office will:
    1. Enter all projects into IRBNet
    2. Upload all required documents
    3. Maintain all projects during their lifetime (i.e., renewals, modifications, closures)
  2. Investigator will:
    1. Review all packages for accuracy
    2. Sign package as required

Communication:

Responsible party within the institution for direct contact with IRBNet is Creighton University IRB office.