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:
Training Guidance
CITI training is required for all personnel listed on human subjects research protocols. Please refer to the Requirements Based on Research Type section of the Investigator Resources page of the IRB website for specific required courses.
CVs/Resumes are required for all listed personnel for all research types, including Quality Improvement and Not Human Subjects Research. Current CVs/resumes must be uploaded in PDF form.
CVs/Resumes must be dated and no greater than two years old. To date a CV/resume, it is recommended that the Biosketch Name (Step 4 in the document below) include the date. For example, “Date First Name Last Name CV/Resume.”
Professional licenses are required when applicable. The license should be current and updated upon expiration.
Individuals conducting funded AND/OR Greater than Minimal Risk AND/OR FDA-regulated research are required to submit Creighton University’s Financial Conflict of Interest Disclosure in InfoEd.
Individuals conducting federally funded research are required to complete the National Institutes of Health (NIH) Financial Conflict of Interest Tutorial and provide their completion certificate.
Guidance for Investigators
IRB Templates and Forms
- Protocol for biomedical or social behavioral research.
- Protocol for NIH funded behavioral and social science research.
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 – For use when a participant signature is not required (waiver of documentation of consent).
- Informed Consent Checklist
- Informed Consent Form – Full informed consent. For use when a participant signature is required.
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.
- HIPAA Authorization - Use for authorization for use and release of health information for research purposes.
- 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.
- The HIPAA for Research Purposes has been revised and simplified. Submitters are instructed to:
- Corrective and Preventive Action (CAPA) Plans – For use when a corrective action plan has been requested.
- Certificate of Translation – For use when the study involves non-English speaking participants.
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.
