Investigator Resources

Human Subjects Research Training, Documentation and Disclosure Requirements

Creighton University’s training, documentation and disclosure requirements apply to anyone conducting human subjects research under the oversight of CU IRB. The following activities qualify as human subjects research:

  • Obtaining, using, or analyzing for research purposes identifiable information generated through intervention or interaction with a living individual
  • Obtaining, using, or analyzing for research purposes identifiable biospecimens (or leftover de-identified biospecimens for FDA-regulated research)
  • Conducting research procedures as a part of a clinical investigation
  • Recruiting or consenting individuals for participation in human subjects research
     

Quick Links:

Requirements for Quality Improvement Projects and Not Human Subjects Research

National Institutes of Health Financial Conflicts of Interest Tutorial (NIH FCOI)

Creighton University Conflicts of Interest Disclosure (CU COI Disclosure)

Curriculum Vitae, Resumes, and Professional Licenses

Note: Current CVs and licenses must be uploaded in PDF form. CVs must be signed and dated on the first page and must be no greater than two years old.

IRB Templates and Forms

Note: When clicked on, these Word documents will automatically download to your computer. Please check your "Downloads" folder.

  • Site Permission – If the research includes study activities taking place at sites other than CU, CHI Omaha locations, or facilities belonging to one of CU’s partner organizations in Phoenix, provide the IRB with a Site Permission letter from each organization/location at which the research is being conducted.

Note: When clicked on, this Word document will automatically download to your computer. Please check your "Downloads" folder.

  • Information Sheet – Short form consent. For use when a participant signature is not required (waiver of documentation of consent).
  • Informed Consent Form – Full informed consent with a signature line.

Note: When clicked on, these Word documents will automatically download to your computer. Please check your "Downloads" folder.

Note: When clicked on, these Word documents will automatically download to your computer. Please check your "Downloads" folder.

Note: When clicked on, this Word document will automatically download to your computer. Please check your "Downloads" folder.

Instructions for Completing the new HIPAA for Research Purposes.

Note: When clicked on, this Word document will automatically download to your computer. Please check your "Downloads" folder.

  • The HIPAA for Research Purposes has been revised and simplified. Submitters are instructed to:
    • Complete the study-specific information at the top of page one (Study Title, IRB Number, PI, etc.).
    • Update the bulleted information in RED on page one as appropriate to your study. Remove CHI Health if CHI is not involved in your study, add the name of the study sponsor if your protocol is funded, and add the names(s) of other partnering institutions as necessary.
    • Check the appropriate box on page three regarding release of medical records. Please read the options carefully.
    • Make no additional edits or changes to the form.
  • If you have questions about completing the form, please call the Research Compliance Office at 402.208.2126. 

Note: When clicked on, these Word documents will automatically download to your computer. Please check your "Downloads" folder.

Submitting to the IRB

The Creighton University IRB uses InfoEd Global to manage protocols submitted to the IRB. Click the link to the right for guidance documents on how to access InfoEd, submit to the IRB, and upload required documents to InfoEd.

Policies and Procedures

Click the link to the right to view the clickable policy manual for the Creighton University IRB.

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