Human Subjects - IRB

Bellarmine University’s Institutional Review Board (IRB) has primary oversight over all human subject 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 Bellarmine University affiliated researchers (faculty, staff, and students) performing research are required to submit research protocols for review and approval. The committee is comprised of Bellarmine University faculty as well as members of the community.

To submit an IRB protocol application package or if you have questions pertaining to the IRB, please send an email to irb@bellarmine.edu.  

Policies and Procedures:

  • Protecting human subjects training
    A protecting human subjects training certificate is required of all investigators listed on an IRB application. 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 in CITI. 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 regarding which module to choose.
    6. Complete the training (estimated 2-3 hours), then save and submit the certificate with the IRB submission.
  • IRB handbook (pdf) - all investigators and students should review the handbook prior to submission.
  • Research Participant Incentive Guidelines (pdf) – required if using participant incentives. 

Levels of Review

The amount of potential risk to participants and the vulnerability of the participant population determines the type of review. According to CFR Title 45 Part 46, “minimal risk means 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.” Certain participant populations are afforded extra protections. These populations include but are not limited to pregnant women, human fetuses, and neonates (Subpart B); prisoners (Subpart C); and children (Subpart D).

The Bellarmine University IRB is the only entity that can make the final determination of which kind of review is necessary for your research proposal. For more information or questions regarding review levels, please refer to CFR Title 45 Part 46 or contact the IRB Committee.

Exempt

To qualify as exempt, the activity must not be greater than minimal risk and must fall into one or more of the exempt categories listed in 45 CFR 46.104(d). These are summarized below. See CFR Title 45 Part 46 for full information on these exempt categories.   

  1. Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction.
  2. Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if appropriate data security criteria are met.
  3. Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and appropriate criteria are met.
  4. Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if appropriate criteria are met.
  5. Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs.
  6. Taste and food quality evaluation and consumer acceptance studies.
Expedited

To qualify for expedited review, the activity must involve no more than minimal risk and must fall into one or more of the 45 CFR 46 “List of Expedited Categories”. These categories are summarized below. See CFR Title 45 Part 46 for full information on these expedited categories.

  1. Clinical studies of drugs and medical devices only when appropriate conditions are met.
  2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture when appropriate conditions are met.
  3. Prospective collection of biological specimens for research purposes by noninvasive means.
  4. Collection of data through noninvasive procedures routinely employed in clinical practice.
  5. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes.
  6. Collection of data from voice, video, digital, or image recordings made for research purposes.
  7. Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
  8. Continuing review of research previously approved by the convened IRB if certain conditions are met.
  9. Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.
Full Review

Studies posing greater than minimal risk will be subject to a full review by the IRB Committee. Protocols requiring full review are vetted by the entire Bellarmine IRB Committee and discussed at a convened meeting. The IRB Committee meets as needed. See CFR Title 45 Part 46 for full information on full review categories.

Required Forms and Documents

Summary Submission Form

Submission Checklist – is included in the submission form

Research Protocol
Please include a research protocol and project description that sufficiently describes what will take place, what is expected of human subjects and any survey/instruments. This should include enough detail such that someone outside of the discipline can understand the objectives and methods associated with the project, so that a review status can be verified or determined. 

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

Copies of any research instrument, survey, etc. that will be used.
CITI certification documentation for each investigator listed.
Vita or resume for each investigator listed.

Other IRB Forms

Quick Links

Contacts

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

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

Connie Smith, IRB Coordinator
csmith6@bellarmine.edu

IRB Committee
  • Christy Wolfe, Psychology, Chair (AY23-24)
  • Frank Hutchins, Anthropology, Vice-Chair (AY24-25)
  • Roberta Challener, Biology (AY23-24)
  • Heather Owens, Nursing (AY24-25)
  • Chris Wingard, Physical Therapy (AY23-24)
  • David Scott, Philosophy (AY23-24)
  • Diane Courington, Education (AY23-24)
  • Rosemarie Young, Education (AY24-25)
  • Matt Ledington, External (AY23-24)
  • Yana Feygin, External (AY24-25)
  • Sonja Bareiss, Physical Therapy, Alternate (AY23-24)
  • Conor Picken, English, Alternate (AY24-25)
  • Jean Lamont, Psychology, Alternate (AY24-25)
IRB FAQs

What about student research in the classroom - Does it need IRB review?

It depends. In most cases, course-based research does not require IRB review if it is performed within the context of an existing course - and not an independent study or honors thesis. For more information, please refer to the IRB Handbook.

What about surveying Bellarmine students?

Bellarmine students may be surveyed or interviewed as part of an IRB approved research project. However, the participants should be "volunteers"—not simply a captive and convenient sample. Additionally, the research must consider that the use of Bellarmine students may prove especially challenging relative to ensuring the confidentiality and privacy of individual participants. In short, if the project can readily be completed using another population of individuals, it is preferable. Also, student researchers would need approval of their instructor to survey BU students and to solicit participants via email. With respect to email surveys, students are not permitted to solicit participation through "mass" email SPAM. Finally, instructors of courses that include survey research should limit the total number of surveys deployed and avoid (if at all reasonably possible) the mass email recruitment of faculty, students, and staff.

What if I have an “adverse event” occur during my data collection?

All adverse events must be reported promptly to the IRB via email irb@bellarmine.edu.

What do I need to do if I need to modify my methods of data collection?

To make changes to your study, including adding procedures, research personnel, or documentation, complete the Amendment/Termination form. Submit the completed form and any new documentation (ex – CV, protecting human subjects training certifications, surveys, etc.) to the IRB via email irb@bellarmine.edu for review and approval.

Can I incentivize research participants?

Yes, however please follow the research participant incentive guidelines. These guidelines can be found above under Policies and Procedures.

If I have a question, who should I contact?

If you have questions about required forms, process, or the status of a pending submission (i.e., protocol), please contact the IRB by emailing irb@bellarime.edu.

If you have questions about research compliance policies, please contact Associate Provost Dr. Mark Wiegand at mwiegand@bellarmine.edu.

If you have other questions that do not fit in the above and may be related to your specific research or writing a protocol/submission, please feel free to contact the IRB, IRB chair or any member of the IRB.