Self-Determinations and Clinical Trials

​​​​​​Self determinations

Exempt and Class Projects Self Determination - Revised (1/23/2023) - Use this to obtain level I approval for educational practices conducted in educational settings, surveys, interviews (including focus groups) and educational testing of adults or to register a class project.

• Review the Level I guidance document for more information for more information about exempt research.
• Review FAQ 11.10 to learn more about class projects - Class Project Consent Form

IRB Review Determination Form — Use this online form (Chrome is recommended) if you are unsure whether your project requires IRB review. 

Clinical Trials

• To determine if you are conducting a clinical trial review NIH Clinical Trial Decision Tree and NIH's Clinical Trial Definition and Basic Experimental Studies Involving Humans Research webpages.
• All personnel engaged in a Clinical Trial MUST complete CITI GCP training.
• All Applicable Clinical Trials must be posted to Clinicaltrials.gov.
  • FDA:https://prsinfo.clinicaltrials.gov/ACT_Checklist.pdf
  • NIH:https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
  • 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:
  • Contact Kevin McCreary at kmccrea1@kent.edu to obtain credentials.
  • Adhere to clinicaltrials.gov's requirements and review the PRS User Guide.
• Clinical Trial and Biomedical Study Consent Template - (new 11/5/21) use this template for clinical trial and biomedical studies. 
• See also - Kent State User ID and Password Required Clinical Research SOPs