Human Subjects Research Education Program
Creighton University requires that all individuals working with human subjects in research complete an educational program in the protection of human subjects. Creighton University has developed the Human Subjects Research Education Program to assist investigators and staff in meeting federal regulations and University education requirements. The Human Subjects Research Education Program includes initial certification as well as ongoing education and recertification.
If you have any further questions, please contact Patsy Nowatzke, Director of the Institutional Review Board (402-280-3586) or the Research Compliance Educational Coordinator at 402-280-2680.
Program Objectives:
- To assist investigators and staff in their understanding of the special requirements associated with the use of human subjects in research
- Clarify the responsibilities of those involved in human subjects research and of the Institutional Review Board (IRB)
- Increase recognition of the basic ethical principles for the use of human subjects: respect for persons, beneficence, and justice
- Provide education on the protection of human subjects as mandated by Title 45 of the Code of Federal Regulations, Part 46 (45 CFR 46) and promulgated by the federal Office for Human Research Protections (OHRP) at the National Institutes of Health
- Provide education on Creighton University IRB review, informed consent, and policies and procedures applicable to human subjects research
- Provide education on the regulations and special requirements associated with the Health Insurance Portability and Accountability Act of 1996.
Who Is Required to Complete the Program?
All research personnel who interact with research subjects in performing elements of protocols are required to complete the Human Subjects Research Education Program, regardless of their position within the study. These personnel include the following:
- Institutional Review Board members
- Principal investigators, co-investigators, sub-investigators, faculty
- All research staff, including study coordinators, study nurses, residents, and individuals who obtain informed consent, administer surveys, or collect identifiable private information
- All other employees listed on protocols that involve the use of human subjects in research
Initial Certification
Initial Certification will be provided when investigators and staff have met the following criteria:
- Verification of receipt of the Creighton University Investigators' Manual for the Use of Human Subjects in Research
- Attendance at a Creighton University IRB On-Site Human Subjects Education Seminar
- Attendance at a Creighton University Institutional Review Board Health Insurance Portability and Accountability Act (HIPAA) Education Seminar (This component may be waived if the Investigator's research protocol does not contain the use of protected health information. Please check with Patsy Nowatzke, IRB Director at 280-3586)
- Completion of the web-based Collaborative IRB Training Initiative (CITI) Human Subjects Research Core Education Module and its associated testing
Please contact the Research Compliance Educational Coordinator at 402-280-2680 to schedule an appointment to view the education seminars.
CITI Information
- CITI course description and instructions (Word document)
- CITI registration page
*Please note - You should register for ONLY Group 1 (Biomedical) or Group 2 (Social Behavioral). The other groups are for administrative purposes.
Ongoing Education and Recertification
In addition to initial education, formal training will be required every 3 years. Creighton investigators and staff will be notified when they must be recertified. The recertification process will include completion of the online CITI Continuing Education Refresher course. Individuals should complete the course most appropriate for the area of research - Biomedical or Social/Behavioral.
**Please print a copy of the completion report for your records.
The recertification process may also include seminars on specialized topics and periodic updates to inform investigators and staff of changes in federal regulations or University requirements. These will be announced as they become available.