A project that includes activities that meet the Federal Government’s definition of Human Subject Research is subject to IRB oversight at Illinois State University. Under 45 CFR part 46 (The Revised Common Rule) research is defined as “a 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 an investigator (whether professional or student) conducting research obtains (1) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens, or (2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.” (section 46.102 - Definitions of CRF Title 45, Part 46, Department of Health and Human Services policy for Protection of Human Research Subjects). The office for Human Research Protections (OHRP) has developed a decision chart to help identify whether or not activities are considered to be human subject research.
For scenarios where researchers either want documentation that their study is not Human Subjects Research or if they want to verify their determination, they can either submit a study in Cayuse IRB or contact the Human Subjects Research Specialist from the Research Ethics and Compliance Office.
All student-led research that will be disseminated beyond the classroom or ISU’s Research Symposium (e.g., research that will be presented at a professional conference, published in a scholarly journal, etc.) is subject to Illinois State’s Institutional Review Board (IRB) review. Class projects (including independent study projects) also require review by the IRB if they contain more than minimal risk encountered everyday or involve a protected class of citizens (e.g., mentally incapacitated or economically disadvantaged).
The following activities are NOT considered to be contributing to generalized knowledge:
- Submitting a paper or presenting the study to an instructor and/or classmates as part of a course
- Using the findings to inform a specific entity
- Presentation at the ISU research symposium
Because these activities are not considered to be contributing to generalized knowledge, projects that only include these three activities do not need to be reviewed by the IRB. (See https://research.illinoisstate.edu/ethics/human/protocol/classproject.php.)
- Faculty are responsible for determining whether a student research project has reached a threshold for IRB review, and they are not relieved of their responsibility to use human subjects in an ethical manner.
- All student research must have a faculty advisor or staff member as the principal investigator (PI).
- The department IRB representative will be responsible for informing faculty of the student research policy and will be available for interpretation of the policy.
- Class-only projects that may be disseminated in the future must be reviewed. IRB approval must be obtained prior to any data collection.
- Class projects designed to “practice” systematic investigation techniques need not be reviewed when such projects involve supervised training of new members of a profession. Examples include teacher trainees practicing evaluation, clinical interns practicing assessment or diagnosis, and student journalism reporters practicing interviewing, etc. These activities should still communicate applicable or reasonable elements of informed consent (e.g., institutional affiliation, purpose of investigation, risks, benefits, voluntary participation, permission to withdraw, etc.). When consent is obtained, it should be made clear that the participant is being recruited for a class project instead of a research study.
- A student engaged to work on a previously approved research project where a portion of the data will be used for a course assignment, independent study, honors project, etc., must have the student’s name submitted by the PI as a modification (for expedited and full board studies) to the original proposal. The IRB must approve the modification before the student becomes engaged in the research. Besides being trained on the protocol, the student will also have to complete CITI training as well. Under the Revised Common Rule and per OHRP guidance, a student would be engaged if they were to access identifiable data, collect data for the study, interact with participants, or directly recruit participants.
- Theses and dissertations are considered generalizable research and must be reviewed if the data being collected involves either interacting with or collecting private information from living human beings.