Training, Documentation and Disclosure Requirements

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