Research with Human Subjects
Research involving human subjects must be reviewed and approved by the Institutional Review Board (IRB) before any aspects of the research commence. The IRB is composed of faculty scientists, faculty non-scientists, and a non-SIUE affiliated member from the community, all of whom work together to protect the rights, welfare and well-being of human subject research participants.
COVID-19 Updates
The SIUE Office of Research and Projects (ORP) has published University Guidance to Investigators During COVID-19 for Human Subject Research that provides guidance for face-to-face human subject research (HSR) on campus and for research field work, in accordance to Governor Pritzker’s Restore Illinois plan and the University’s plan for phasing in general operations. Those guidelines can be found here under "Human Subjects."
Additionally, all Investigators conducting any face-to-face research studies involving interviews, focus groups, etc., must provide each participant with the Research Participant Safety Acknowledgement Form (COVID-19).
If you have any questions, please feel free to reach out to the office of Research and Projects at irbtraining@siue.edu.
STEP 1 IRB Submission
When starting a project that involves interacting with or collecting data about people (e.g. surveys, interviews, and or data collection), it is not always clear whether or not you are conducting human subjects research (HSR) which requires approval by the Institutional Review Board (IRB). All projects that involve human subjects must be vetted by the IRB to determine review before the project can begin. The Graduate School’s Office of Research & Projects has developed a screening method within the Kuali electronic protocol system which will help to determine if your project requires IRB review and approval.
You can see a full list of Common Rule definitons here, however, the IRB encourages completion of the screening tool for all projects involving interaction with or data collection about human subjects.
Complete this step and submit a protocol early because IRB determination and review may take multiple weeks. The following approximation timelines are provided but note that it is impossible to determine exactly how long a review will take:
- exempt review 1-3 weeks
- expedited review 3-6 weeks
- full board review 4-8 weeks or longer.
To make sure your protocol falls within these estimated review times, check out our IRB Guide Presentation that details the IRB process and includes helpful tips on filling out a Kuali Research Protocol. There is also a presentation focused on faculty research in IRB and IACUC you can find here.
Note: exempt and expedited protocols are reviewed on a continuous rolling basis. Full board protocols are reviewed during IRB full board meetings which take place once a month. The deadline to submit a full board human subjects research IRB protocol to the IRB is always the 2 weeks before the second Wednesday of the month in which you would like for it to be considered.
STEP 2 Complete Required CITI Training
If the IRB Administrator determines your project requires IRB review, all investigators on the project are required to complete mandatory human subjects training before the IRB can approve the protocol. From the list of courses offered, choose one or more of the following:
- "IRB Social Behavioral Student"
- "IRB Social Behavioral Faculty"
- "Biomedical Researcher"
- "Group 1, Faculty, Staff or Student Conducting Research Involving Human Subjects" (Choose this course if you are wanting to take a "refresher" of your previous version of this course or if you began this course at an earlier date and wish to finish. Otherwise, choosing one of the courses listed above is recommended.)
STEP 3 Submit Your Protocol
Log into the Kuali Online IRB Protocol System to create and submit your protocol. An online tutorial is available.
Faculty may direct their students to the SandBox Practice Site to create protocols in the offline system for teaching purposes only. These protocols are not live and will NOT be reviewed by the IRB. This site will allow students, faculty, and staff to learn the system before submitting a protocol in Kuali Research for IRB review.
STEP 4 Insurance
If student-initiated (student PI) research could result in the physical, mental, or emotional harm of a person or physical damage to property, the student will need to obtain insurance and provide proof of that insurance to the Compliance Coordinator prior to protocol approval.
The SIU Risk Management Office provides information regarding potential sources of insurance and the required coverage.
For questions, contact SIU Legal Counsel (Jennifer Wagner at jennwag@siue.edu or 618-650-2455) or SIU Risk Management at 618-536-3331.
STEP 5 Investigator Responsibilities Following IRB Approval
Investigators must carry out the research as specified in your approved IRB protocol. Log into the Kuali Online IRB Protocol System if the following occur:
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You would like to propose changes to your approved project. These changes must be submitted to the IRB for approval before they are implemented. In the Kuali protocol, click “Amend” and describe your changes in the Justification section and make other necessary changes within the protocol. Submit these changes to the IRB for review and approval.
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You were instructed by the IRB to submit an annual report.
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You were instructed by the IRB to submit a completion report.
STEP 6 Other items
Unanticipated Problems and/or Serious Adverse Events must be reported to the IRB in a timely manner by contacting the IRB by email at irbtraining@siue.edu.
Related Resources for Human Subjects Research
