Consistent with our core values, Saint Leo University is committed to the safety and protection of those participating in research. The Saint Leo University IRB is charged with review and approval of research involving human subjects conducted in association with our campus community. The Saint Leo University IRB ensures compliance with the ethical principles of research articulated by the U.S. Department of Health and Human Services.
To submit a proposal to the Saint Leo University IRB, please review the application submission procedures before completion of the IRB application and appropriate IRB consent form(s).
The Saint Leo IRB operates on the same schedule as our continuing education centers and COL. It is not active for Thanksgiving week-end (Thursday to Sunday) and during the centers and online end-of-year holiday break, between Fall 2 and Spring 1. Any application received during this period will be considered received the first day activities resume.
For additional information regarding submission to the Saint Leo University IRB, please refer to IRB FAQs or email any queries to email@example.com.
Who Should Submit an Application?
You should submit a complete IRB application if you are conducting research that involves the use of human subjects or information obtained from human subjects. Your first step is to determine if what you are planning to do qualifies as research, or as a class activity. Please read the definitions below to make this determination.
What is Research?
According to the Department of Health and Human Services (2009), research involving human subjects as follows
A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
According to this definition, a study must be systematic and designed to contribute to generalizable or transferable knowledge in order to be considered research that must meet the requirements of the human subject regulations. Although publication is often viewed as evidence of research status, it is not the only criterion. In general, activities that contribute to generalizable knowledge are those that:
- Attempt to make comparisons or draw conclusions from the gathered data;
- Attempt to reach for generalizable principles of historical or social development;
- Seek underlying principles of laws of nature that have predictive value and can be applied to other circumstances for the purpose of controlling outcomes;
- Create general explanations about all that has happened in the past; or
- Predict the future.
Generalizable knowledge is not limited to quantitative studies designed to produce generalizations. Qualitative studies may also contribute to generalizable knowledge through the use of focus groups, case studies, ethnographies, interviews, or other means to identify general themes that the reader can choose to transfer to another situation. A research project is also an original work that has never been conducted before using the exact same research design as the one proposed by the Principal Investigator.
Steneck (2007) clarifies the DHHS definition by saying that "a project or study is research if it is conducted with the intention of drawing conclusions that have some general applicability and uses a commonly accepted scientific method. The random collection of information about individuals that has no general applicability is not research" (p. 39).
Researchers conducting contract research or market research should contact the IRB at firstname.lastname@example.org check whether their activities fall under the definition of research for IRB purposes.
What is a Class Activity?
A class activity is defined as a homework assignment required for the completion of a course offered at Saint Leo University. It does not need to be submitted for IRB review if it falls under the following parameters:
- The activity is conducted by students only as part of the requirements for a course, and under the supervision of the course instructor.
- The results will only be shared in the context of the class; excluding any presentation or report to an audience outside of the classroom for which it is completed.
- The goal of the activity is NOT to contribute to generalize knowledge. Students may collect and analyze data using scientific methods, but the protocol is too limited to permit any valid contribution to the general body of scientific knowledge.
- The activity does not involve any risk to participants beyond those of daily life.
- The participants do not belong to a sensitive population.*
- The project guarantees complete anonymity to the participants.**
- The project does not involve the generation of original knowledge, i.e., does not result in new findings that could not be found in an existing publication, or does not use an innovative methodology.
Instructors are responsible for making sure that any participants in the activity are voluntary, and that any permission to conduct the activity has been properly obtained. They should check the IRB guidelines and application form for more information on populations, topics, and procedures that may involve risk to the participants. Instructors will be held responsible for any violations of the IRB guidelines.
*Sensitive populations are groups who may be at greater risk when participating in research, due to their special circumstances. They include (but are not limited to) minors, individuals diagnosed with a mental disorder or illness, terminally-ill patients, incarcerated individuals, undocumented immigrants, convicted felons. It is the responsibility of the instructor to assess, in the context of the class activity, whether or not other groups qualify as sensitive populations.
*Saint Leo University IRB does not review any studies which include incarcerated individuals as participants.
**Anonymity means that absolutely no information that could identify a participant individually will be collected or reported.
**** Students cannot conduct research projects involving legal risk to subjects / participants. This would include those who are currently involved as offender / defendant in a criminal justice system (such as federal / military/ state / local) or others at legal risk or potential legal risk as a result of study participation.
***** In the event of a change in faculty advisor, the student PI will submit a modification that includes the name / contact information for the new faculty advisor along with the new advisor’s signature and current ethics certification / training (such as certificates from NIH or CITI).
Iowa State University Institutional Review Board. 2009. “Research Requiring IRB Review.” Ames, IA: Iowa State University. Retrieved October 21, 2010 (http://www.compliance.iastate.edu/irb/guide/docs/Definition%20of%20Research.pdf).
U.S Department of Health and Human Services.2009. Code of Federal Regulations Title45 Part 46 Protection of Human Subjects. Washington, DC: U.S Department of Health and Human Services. Retrieved November 8, 2010 (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.102).
Application Submission Procedure
Research Ethics Certification
The Saint Leo IRB requires that all Principal Investigators and faculty advisors include proof of research ethics certification or ethics training transcript with their applications. Applications that do not include a current certificate or transcript (see additional information below) for the PI and the Faculty Advisor in the case of student applications, will be considered incomplete and sent back to the PI without review.
All nationally-recognized certifications addressing the ethics of research involving human subjects, such as the NIH or CITI (Collaborative Institutional Training Initiative) certification, are acceptable. Institution-specific trainings are not. If you are not sure whether your certification will qualify, please submit it for review at email@example.com.
For members of the Saint Leo community who do not already have a certification, or who need to renew a CITI certification, Saint Leo University provides access to the CITI program, using your Saint Leo username and a password of your choice. In case of technical difficulties with this site, please contact the IRB office at firstname.lastname@example.org.
Faculty and Staff
Certification is valid for 3 years. For those taking the CITI training, the basic training for Social and Behavioral sciences is recommended. Applicants whose certification has expired should take the refresher course and submit their updated certification with their application.
Certification is valid for 1 year. Those taking the CITI training need to register as “Student Researchers” to access the student modules. Unless told otherwise, by your instructor, all students should take the “Student – Class Projects” Citi training course. Please note that the “Good Clinical Practice Course” is not acceptable. Applicants whose certification has expired should take the refresher course and submit their updated certification with their application.
Requesting an Extension or a Modification
IRB approval is valid for one year from the date of approval. PIs planning to continue data collection and/or analysis beyond their expiration date need to request an extension of their approval by email to email@example.com, before the approval expires. The email should include a justification for extension, and an attached copy of the approved application from the past year.
Requesting Approval of Research Design Modifications
PIs deciding to modify their research design after their application has been approved should request approval for the modified application by submitting to firstname.lastname@example.org their modified application, with the modifications highlighted in yellow, as well as the original, approved application from their original submission. They should also explain the nature of the modifications and justify their necessity in their email to the IRB.
Requesting Approval of a Change of Faculty Advisor/Chair
Student PIs who have had a change in their faculty advisor after IRB approval should request approval for the modified application by submitting their modified application, which includes: advisor’s name and email address, marked checkboxes for the Faculty Advisor, new signature and date, and new advisor’s current ethics Certification to IRB@saintleo.edu
They should also submit the original, approved application from their original submission.
Frequently Asked Questions
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.
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.
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.
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).
View the Application Submission Procedure to see the steps involved in submitting your proposal to the IRB.
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.
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 email@example.com.
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.
IRB Application Directions and Forms
Directions, Definitions, and Training
- Application Review Process
- Training for Faculty and Students
- Training for Doctoral Faculty and Doctoral Students
- IRB Training PowerPoint - Tips for Successful Applications
- Defining Minimal Risk
Application and Consent forms
- IRB Application
- Types of Consent
- Assent Form
- Implied Consent Form
- Informed Consent Form
- Informed Consent Form - Parents and Guardians
- Informed Consent Form Photo and Video
- Passive Consent Form (opt-out-form)
IRB Applications and general inquiries should be emailed to firstname.lastname@example.org. Failure to use this email address to submit an application may result in a delay in the review.
Any and all other inquiries regarding the IRB should be directed to the IRB Chair or, in his/her absence, to the IRB Co-Chair.