Overview

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.

Click here for a video walking you through the Viterbo IRB application process

Instructions

Follow these steps if you plan to conduct a Human Subjects Research (HSR) project:

1. 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. Information regarding exemptions can be found here.
   
   Studies will be considered for an expedited review if any of the following criteria are met:
   1. Research procedures present no more than a minimal risk to participants. Minimal risk is defined by federal regulations as meaning that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
   2. A vulnerable population (such as children, prisoners, pregnant individuals, individuals with cognitive impairment, or economically/educationally disadvantaged persons) is not used as participants.
   3. Identification of the participants and/or their responses would not reasonably place them at risk of criminal or civil liability or be damaging to their financial standing, employability, insurability, reputation, or be stigmatizing.
   4. The study does not involve deception of participants.
2. 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.
   1. 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 email address to create the account.
   2. 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.
   3. Complete the course.
   4. 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.
3. 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 email address to create an account.
4. Login to Virbatim to complete an application.
   1. 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.
   2. 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.
   3. 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.
5. 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 email 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 at irb@viterbo.edu or 608-796-3671 with general application processing questions and concerns including any issues with Virbatim.
• Contact the IRB Chair (Dr. Kelsey McLimans) at kemclimans@viterbo.edu or 608-796-3663 with specific application and research project issues.

Data Security Information

Participant confidentially is of the utmost importance.  The following are best practices for preventing unintentional disclosure of confidential information.

• Utilize OneDrive, if possible, for safe storage of documents and only allow access to the folder to those listed on IRB application
• If you are conducting research at an outside organization, follow all HIPAA guidelines: https://www.hhs.gov/hipaa/for-professionals/index.html as well as organizational regulations for data use and storage
• Have a separate key that links participants with research IDs, that is kept in a separate, safe location (i.e. separate OneDrive folder, etc.) and only include participant ID on all data collection forms, Excel spreadsheets, etc.  
• Only utilize Qualtrics platform for online surveys unless substantial reason to use a different platform
• Click “anonymize responses” in Qualtrics so IP addresses and other identifying information is not collected.  This is under the “security” tab in Qualtrics
• If you do not need to collect participant names or other identifying demographic information for survey research, do not collect this information
• Keep research data in safe, password-protected locations, electronically, or in a locked filling cabinet on Viterbo campus for hard copies.  Immediately scan documents with identifying information, upload into OneDrive, and shred documents, or store in a locked filing cabinet on Viterbo campus
• Keep signed informed consent documents separate from all other data, as the consent document contains names, which could identify participant data

External Resources

• Department of Health and Human Services (HHS)
• Office for Human Research Protections (OHRP)
• Federal Regulations (45 CFR 46)