Defining human subjects research
Human subject research is defined by the Office of Human Research Protections in 45 CFR 46.102. A clinical investigation is defined by the Food and Drug Administration in 21 CFR 50.3(c). Research that meets either of these definitions must be reviewed by UIUC IRB.
Only the UIUC IRB and OPRS have the authority to determine whether the research UIUC faculty, staff, and students are conducting is considered human subject research. Individual investigators cannot make the determinations on their own.
New Study Application Submission Requirements
Investigators applying for any initial approval of a proposed research protocol must submit a completed New Study Application form. The form is submitted via the IRBOnline system. https://irbonline.research.illinois.edu/
Consent documents, recruitment materials, questionnaires/surveys, interview scripts and other documents that may be required for review are uploaded as part of the application in IRBOnline.
The Principal Investigator is responsible for the overall conduct of the research, including submission of the IRB application. While individual tasks may be delegated to research team members, including completion of the application forms, the information submitted is the responsibility of the PI.
Eligibility criteria for Principal Investigators is defined within the Campus Administrative Manual.