Training, Documentation, and Disclosure Requirements

Human Subjects Research Training, Documentation, and Disclosure Requirements

CUís 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

Who Needs to be Included on Faculty and Student Protocols: (PDF)

Requirements Based on Research Type:

  • Biomedical (IRB-01) HSR Requirements (PDF)
  • Social Behavioral (IRB-02) HSR Requirements (PDF)

Requirements for Quality Improvement Projects and Not Human Subjects Research:

  • Biomedical and Social Behavioral QI/NHSR Requirements (PDF)
  • Is this quality improvement (HHS Guidance)? LINK

Guides to Completing Requirements:
CITI Program Training

  • Sign Up for CITI: LINK
  • Add New Courses to Existing Account: LINK
  • Add/Change your affiliated institution: LINK

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

Creighton University Conflicts of Interest Disclosure (CU COI Disclosure)

  • File New Fiscal Year Disclosure and Updating as Necessary: LINK

Curriculum Vitae, Resumes, and Professional Licenses

  • Upload CVs, Resumes, and Licenses in InfoEd: LINK
  • 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.