Human Subjects - IRB

Bellarmine University’s Institutional Review Board (IRB) has primary oversight over all human subjects research and is charged with protecting research participants and the public.

The authority and duties of the IRB are defined by the Department of Health & Human Service’s Office of Human Research Protections under CFR Title 46 Part 46. As such, all BU affiliated researchers (faculty, staff, and students) performing research are required to submit research protocols for review and approval. The committee is comprised of BU faculty as well as members of the community.

Policies and Procedures:

  • A human subjects training certificate is required of all PIs seeking IRB approval for research projects. No submitted protocols will be reviewed without a verification certificate from the approved tutorial. All investigators are required to renew their human subjects training every three years. Bellarmine has a subscription to training modules produced by the Collaborative Institutional Training Initiative (CITI). If you currently have a NIH Certification of Completion for human subjects training, then that is acceptable until the expiration date. At that point you will need to complete the Human Subjects Research (HSR) module most appropriate for your project. Please follow these steps to access the HSR training:

    1. Access the CITI website at https://about.citiprogram.org/en/homepage/
    2. If you are new to CITI training, click on the “Register” button in the top right corner of the page
    3. Create your username and password, then proceed to the “Courses” pulldown menu
    4. Click on the tab “Human Subjects Research (HSR)”
    5. Based on the nature of your research, choose either the “Biomedical (Biomed) Basic” module or the “Social-Behavioral-Educational (SBE) Basic” module. NOTE: Students should get advice and approval from their advisors or the faculty member assigning the research project with regard to which module to choose
    6. Complete the training (estimated 2-3 hours), then print and submit the certificate with the IRB submission
  • IRB Handbook (pdf) - All investigators and students should review the handbook prior to submission
  • IRB Decision Flowchart

Exempt Studies - Some survey work, where no subject identifiable information will be collected, may qualify for exempt status and an experienced researcher can often know this before submitting a full IRB proposal. If you have any questions, please contact the IRB Chair.

  • IRB Short Application for Exempt Review - exempt studies only (pdf) - please include a project description that sufficiently describes what will take place, what is expected of human subjects and any survey/instruments. There should enough detail that someone outside the discipline can understand the objectives and methods associated with the project, so that exempt status can be verified.

Non-exempt Studies - Research requiring expedited or full review.

Informed Consent - All human subjects research requires investigators obtain the informed consent of participants.

Other IRB Forms

IRB forms can be submitted via email to irb@bellarmine.edu.

Frequently Asked Questions

Contacts 

Dr. Christy Wolfe, IRB Chair
cwolfe@bellarmine.edu

Dr. Frank Hutchins, IRB Vice Chair
fhutchins@bellarmine.edu

Connie Smith, IRB Support Staff
csmith6@bellarmine.edu