Guidance Documents

The following documents provide investigators with information that will be helpful for meeting the standards set by the Wright State IRB based upon the federal regulations for the protection of human subjects in research. Additional topics will be added on an ongoing basis.

Investigator Instructions

• Cayuse Human Ethics Quick Start Guide
• Cayuse Human Ethics Investigator Guide (Full)
• Cayuse Legacy Conversion Guide
• Cayuse Investigators Guide - Navigation
• Cayuse Investigators Guide - Creating New Protocol
• Cayuse Investigators Guide - Certify Submission
• Cayuse Investigators Guide - Checking Status
• Cayuse Investigators Guide - Editing & Resubmitting a Reopened Submission
• Cayuse Investigators Guide - Finding Approval Documents
• Cayuse Investigators Guide - Modification
• Cayuse Investigators Guide - Renewal
• Cayuse Investigators Guide - Incidents
• Cayuse Investigators Guide - Closure

Researcher Credentialing Requirements

• CITI Training Requirements & How to Enroll
• CV Requirements & Upload Instructions
• Conflicts of Interest Disclosure Instructions
• Human Research Scientific Merit & Feasibility Attestation Form

Common Rule Update 2018

• Brief Overview
• Revised Common Rule Training for Investigators
• Guidelines for Implementing Revised Common Rule

Special Considerations

• COVID-19 Safety Plan (DOCX)
• Use of Deception in Research
• Research Involving the Department of Defense
• Research with FERPA Protected Educational Records
• FERPA Studies Exception Form
• Data Security Guidance for Human Subject Research
• Case Report Guidance
• Class Assignment Guidance
• Public Health Surveillance Guidance
• Umbrella Protocol Guidance
• Quality Improvement (QA/QI) Guidance
• Corrective and Preventive Action Plan (CAPA) Guidance
• CAPA Template
• Faculty Research with Students in their Classes Guidance
• Research Rubric Examples
• Incidental Findings Guidance
• Subject Re-Consenting Guidance
• Remote and Electronic Consent Guidance