Illinois State University is committed to protection of the rights and welfare of human subjects participating in research investigations under the authority of the university. All research involving human subjects is to be conducted in accordance with relevant federal regulations and University policy. Federal regulation requires that all institutions receiving federal funds, which conduct research using living humans as subjects, establish and operate an Institutional Review Board (IRB) to ensure the protection of these human subjects.
New Federal Regulations went into effect January 21, 2019. A new Cayuse IRB submission template will go live on that date that incorporate the regulatory changes. All initial submissions received on or after January 21 will be reviewed under the new regulations. Studies approved prior to January 21 may continue through completion under the pre-2018 rule and will not be expected to comply with all of the changes generated by the Revised Rule. However, if a PI wishes to transition an existing study into the Revised Common Rule, REC should be contacted to discuss options since the study would have to comply with all applicable revised common rule requirements.
Key regulatory changes include:
Updates on the changes are being developed and will be added to the website.
Research Activities Requiring IRB Review
Any research involving the use of human subjects must be reviewed and approved by the IRB.
Research means any systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
A human subject is a living individual about whom a research investigator (whether faculty, staff or student) obtains: (1) data through intervention or interaction with the individual or (2) identifiable private information or records.
The Revised Common Rule has provided determinations on select activities that are considered “not human research and do not require IRB review” as long as they are done exactly as described below (broader use may require IRB review). These include:
Program reviews and assessments, student-led research, or similar activities that will not be disseminated beyond the classroom or university-sponsored research symposium do not meet the definition of human subjects research and do not require IRB review. NOTE: If a student has not received IRB approval for the project, the data cannot be used later for a thesis, dissertation, or any scholarly publication or presentation.
All of the following research activities involving human subjects are subject to the review and approval of the IRB:
Only ISU faculty members, faculty associates or staff can act as the Principal Investigator on a protocol. PIs must certify all initial submissions, modifications and continuations.
IRB review and approval of international research involves a number of challenges, including local laws and customs, translation of consent and research materials, and the security of subjects and data.