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 of the rights, welfare and wellbeing of human subject research participants.
IRB Review Procedure
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.
STEP 1 Determine if your project requires IRB review
Consider the following two definitions. If your project fits both definitions, you will need IRB review.
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge (generalizable knowledge is described as activities intended to be presented at regional, national or international meetings and/or published in an academic/peer-reviewed journal or a non-peer reviewed format intended to influence behavior, theory, or experimental design).
By federal regulations, the following activities are deemed NOT to be research for the purposes of IRB review and, therefore, do not need IRB review:
- journalistic activities such as oral history, journalism and biography
- public health surveillance activities
- collection and analysis of information for criminal justice purpose
- activities in support of national security missions.
Human Subject means a living individual about whom an investigator (whether professional or student) conducting research obtains information or biospecimens through intervention or interaction with the individual and uses, studies, or analyzes the information or biospecimens.
The full list of Common Rule definitons is available here.
STEP 2 Complete required training
All investigators on the project are required to complete mandatory human subjects training before the IRB can approve the protocol.
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
