The Institutional Review Board (IRB) reviews and approves all Human Subjects Research conducted by Viterbo University faculty, staff, and students to ensure the protection of research participant rights and welfare.
The IRB ensures that researchers comply with the federal regulations and ethical guidelines set forth by the Department of Health and Human Service's (HHS) Office for Human Research Protections (OHRP). Viterbo University has filed a Federalwide Assurance in which we promise to comply with these regulations and guidelines. Viterbo's IRB strives not only to ensure that researchers comply with federal regulations but also more generally to foster appreciation for the ethical principles of beneficence, justice, and respect for persons. Researchers honor Viterbo's mission and core values by upholding these ethical principles.
Follow these steps if you plan to conduct a Human Subjects Research (HSR) project:
- Determine if your project satisfies the federal definitions of Research and Human Subjects (and therefore requires IRB approval) using the interactive decision tree:
DO YOU NEED TO SUBMIT YOUR PROJECT FOR IRB APPROVAL?
If questions remain after completing the decision tree, contact the IRB Chair. Complete the remaining steps if your project requires IRB approval.
- All investigators involved in a project must complete research ethics training and provide evidence of certification within the past three years. Viterbo maintains a relationship with CITI Program to provide this service.
- Navigate to the CITI Program website and select Register to make an account. Select Viterbo University from the organization affiliation list on the registration page. Use your Viterbo e-mail address to create the account.
- During the registration process you will be asked to select your curriculum. There are quite a few courses/certificates available to you through this service and you are encouraged to explore the options; however, for IRB purposes you are expected to complete one of the following courses (presented in Question 1 of the curriculum selection process): Biomedical Research Investigators or Social & Behavioral Research Investigators. Select the option that best aligns with your research endeavors. If you are not interested in other courses at this time you can safely ignore the other questions, scroll to the bottom of the page, and click Submit. You can always add courses later.
- Complete the course.
- Upon completion, View/Print your completion certificate and download the PDF. You will need to upload this file for IRB review. The certificate is acceptable as evidence for research ethics training for three years from the date of completion.
- Download and read through the Virbatim User Guide (MS Word) and follow the instructions to create a Virbatim account and learn how to navigate the site. You will need your Viterbo ID number and e-mail address to create an account.
- Login to Virbatim to complete an application.
- An application template is available on the forms page of this website. You may find it helpful to compose responses in the template and transfer them to your project in Virbatim upon completion. Note that other forms on that page are useful for you, particularly the consent form template.
- After the application form is complete you will be asked to upload supporting documents. Review the list carefully and make sure to upload all applicable documents.
- Before submitting your project, read through the IRB Review Checklist (PDF) and make sure that all expected components are included, complete, and accurate. The checklist is used by IRB committee members during the review process.
- Wait patiently for a review of your application by assigned IRB committee members. Once the review is complete, the IRB Chair will evaluate the reviewer feedback and either submit approval of your project or post correspondence for you on the PI Correspondence page of your project in Virbatim.
Most projects are not approved upon initial submission and it is reasonable to expect correspondence, which usually occurs within 10-14 days for Exempt applications or 14-21 days for Expedited applications. Projects that require Full review will be discussed at a scheduled committee meeting and the IRB Chair will post correspondence after this meeting.
You will receive a message via e-mail when correspondence is posted; at that time, carefully respond to reviewer comments/questions/concerns as directed.
Note that the review process slows significantly during very busy times (end of Fall, Spring, and Summer terms) given the high volume of applications.
Need some help?
- Contact the IRB Administrative Assistant (Bobbi Hundt) at firstname.lastname@example.org or 608-796-3671 with general application processing questions and concerns including any issues with Virbatim.
- Contact the IRB Chair (Dr. David Bauer) at email@example.com or 608-796-3712 with specific application and research project issues.