Frequently Asked Questions
All information listed below can be found in more detail in the Investigators' Manual for the Use of Human Subjects in Research.
Getting Started
I haven't worked with human subjects before at Creighton University. What are the requirements to have a project reviewed by the IRB?
- All personnel listed on the protocol must have a certificate of completion for Creighton University's Institutional Review Board Human Subjects Research Education Program on file in the Research Compliance Office.
- The original and fifteen double-sided copies of all required documentation for the specific protocol with the IRB Application for Full Board Review must be submitted to the IRB office a minimum of two weeks prior to the scheduled meeting time.
- You must schedule an appointment for your protocol to be reviewed. Please see the Investigators' Manual for the Use of Human Subjects in Research, IRB Policies and Procedures, 5.3.3.1 for more information.
How do I know if my project is exempt?
Please see the Investigators' Manual for the Use of Human Subjects in Research, IRB Policies and Procedures, 5.2.1. You may also contact Patsy Nowatzke, IRB Director for questions regarding the exempt categories. Exempt projects must be reviewed by the IRB Office.
How can I get help with the application process?
If you still have questions after reviewing the Application for Full Board Review, please contact Patsy Nowatzke, IRB Director. Additional information can also be found in the Investigators' Manual for the Use of Human Subjects in Research, IRB Policies and Procedures, 6.0.
How does the protocol review process work?
Applications are reviewed bi-monthly at the IRB meetings by the full committee. Principal Investigator's are required to attend the meeting for review of new applications to address any questions or concerns about the protocol. Please see the Investigators' Manual for the Use of Human Subjects in Research, Policies and Procedures, 5.6 for IRB Review Criteria and 5.3.3.2 for the IRB Review Process.
Contact Patsy Nowatzke, IRB Director for questions or if you wish to appeal any decision made by the IRB.
How long is a project valid?
A project is valid for up to one year dependant upon risk. The risk categories and approval period are as follows:
- High Risk - six months
- Moderate Risk - nine months
- Low Risk - twelve months
All approved protocols are reviewed annually, and Principal Investigator's must complete the Reporting form for Continuing Review or Project Termination as part of this process. This form is mailed to the Principal Investigator in time for renewal. Failure to provide the requested information on time will result in suspension of the protocol. This form must also be submitted if work on a project is continuing after the closing date of the original project or if the project is to be terminated. This form must be submitted to the IRB Office at least two weeks prior to the meeting date in which your project is scheduled for review. It is your responsibility to make sure that your project is scheduled for review by the IRB office prior to the protocol expiration date.
The IRB Office will inform you by letter when your project is due to expire. If you are due to expire and have not received a letter please contact the IRB Office.
Please see the Investigators' Manual for the Use of Human Subjects in Research, Policies and Procedures, 5.1.3 for more information.
What if I need to make changes to my project?
Please see the Investigators' Manual for the Use of Human Subjects in Research, Policies and Procedures, 5.1.2 for more information.