IRB FAQs

Frequently Asked Questions

Q. What is the SLU-IRB?
A.
Consistent with our core values, Saint Leo University is committed to the safety and protection of those participating in research. The SLU-IRB (Institutional Review Board for the Protection of Human Subjects) is charged with protecting the rights and safety of participants in biomedical, social and behavioral research. The IRB requires compliance with basic ethical principles of research articulated by the U.S. Department of Health and Human Services. Saint Leo University maintains an IRB that reviews, approves and certifies that staff, faculty, and student researchers are indeed protecting their human subjects.

Q. What types of research must be submitted to the IRB?
A.
All research involving the collection of data from human subjects must be submitted to the IRB for review. Some research activities are exempt from IRB review. Please see Who Should Submit an Application for detailed information.

Q. How do I know if my research will be exempt, expedited, or will require a full board review?
A.
Research that is exempt falls within 6 categories defined by federal regulation and involves little or no risk to the participants. Please refer to the Application Review Process on this website or refer to the U.S. Department of Health and Human Services Basic HHS Policy for Protection of Human Research Subjects.

Expedited review includes research for which each of the procedures falls within one of the Expedited review categories 1-7 as outlined by the Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA). See the Application Review Process on this website or refer to the U.S. Department of Health and Human Services Basic HHS Policy for Protection of Human Research Subjects.

Your study will require a full-board review if it involves vulnerable subjects such as children, pregnant women, persons with disabilities and/or mental illness, prisoners, and those who are institutionalized. It may also require Full-board review if the research procedures have a higher level of risk and may potentially cause harm to the subject.

If you are unsure of the category of your research, please contact the IRB Chair or Co-chair.

Q. How long will the review process take?
A. Exempt
reviews take about 10 days to complete. Expedited reviews will take 15 days to be completed. Full board reviews are completed at the next regularly scheduled IRB meeting (the 3rd week of each 8 week semester).

Q. How do I submit a research proposal to the IRB?
A.
View the Application Submission Procedure to see the steps involved in submitting your proposal to the IRB.

Q. I think my research is exempt. Do I still need to submit my proposal to the IRB?
A.
Yes. All research that involves human subjects must be submitted to the IRB Co-chairs for determination of exemption. Please refer to Who Should Submit an Application for clarification.

Q. What do I need to do if I make changes to my study?
A.
Some changes must be submitted for review and receive IRB approval before the changes can be implemented. Any change that is substantive such as a significant change to research protocol and participants, the risk-benefit ratio, and/or principle investigators may involve resubmission. Highlight any changes made to the protocol or informed consent form and submit with an e-mail noting the changes to irb@saintleo.edu.

Q. What is the difference between anonymity and confidentiality?
A. Anonymity
is when participants are not identifiable from the data collected. Confidentiality is when they may be identifiable but for the protections you have put in place.

Q. Who do I contact if I have questions regarding research and the IRB?
A.
You may e-mail irb@saintleo.edu. or contact the current IRB chair or co-chair.

Q. Who do I contact if I have serious concerns about the welfare and safety of research participants, or about misconduct involving human subject research?
A.
You may e-mail irb@saintleo.edu. or contact the current IRB chair or co-chair.

Other Questions
Please e-mail the SLU-IRB at irb@saintleo.edu.