Applications (Level I, II/III and determinations)
Information on levels of review - review this document to learn about levels and categories of IRB review.
Common mistakes and questions - this has been newly cross posted from the IRB help page.
Level 1 Exemption Application — Revised (9/28/20) Examples include, but are not limited to: anonymous surveys, use of existing data, certain research performed in educational settings or on typical educational processes.
Level II and III Research Application — Revised (9/28/20) Examples include but are not limited to: research conducted on human subjects that involves use of vulnerable populations, sensitive subjects, more than minimal risk for participants, suicidal thoughts, mental illness, substance abuse, use of devices and/or drugs/supplements, invasive procedures.
Exempt Self Determination - Re-released (2/3/20) - Use this to obtain level I approval for educational practices conducted in educational settings, surveys, interviews (including focus groups) and educational testing of adults. Review the Level I guidance document for more information and additional exclusions. Approvals are processed by the Office of Research Compliance; there is a small possibility more information will be requested.
IRB Review Determination Form — Use this online form (Chrome is recommended) if you are unsure whether your project requires IRB review. For your information, this WORD DOC includes the determination form.
- To determine if you are conducting a clinical trial reviewNIH Clinical Trial Decision Tree and NIH's Clinical Trial Definition webpage.
- All personnel engaged in a Clinical Trial MUST complete CITI GCP training.
- All Applicable Clinical Trials must be posted to Clinicaltrials.gov.
- Some journals may require posting even you are not conducting an Applicable Clinical Trial:http://www.icmje.org/about-icmje/faqs/clinical-trials-registration/
- Registration on Clinicaltrials.gov:
- See also - Kent State User ID and Password Required Clinical Research SOPs